The Oncology Institute of Hope & Innovation
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 21 Trials 
240 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Demeure, Michael
PRECISION 1, NCT05103358: Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes

Active, not recruiting
2
120
US, RoW
nab-sirolimus, ABI-009
Aadi Bioscience, Inc.
Tumor, Tumor, Solid, Metastasis, Metastatic Cancer, Cancer, Cancer Metastatic, Tumors, Neoplasms, Neoplasm Metastasis, Solid Tumor, Advanced Solid Tumor, Advanced Cancer, Malignant Solid Tumor, Malignant Solid Neoplasm, Malignant Neoplasm, Malignant Tumor, TSC, TSC1, TSC2, Metastatic Solid Tumor, Metastatic Neoplasm
12/24
12/25
NET-202, NCT05997056: Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors

Recruiting
2
21
US
nab-sirolimus, ABI-009
Aadi Bioscience, Inc.
Neuroendocrine Tumors, NET, Pancreatic Neuroendocrine Tumor, Gastrointestinal Neuroendocrine Tumor, Pulmonary Neuroendocrine Tumor
05/25
12/25
LIBRETTO-001, NCT03157128 / 2017-000800-59: A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

Hourglass Jan 2022 - Dec 2022 : Submission for lung cancer
Hourglass Apr 2022 - Dec 2022 : Approval in China for RET+NSCLC, medullary thyroid cancer and thyroid cancer
Checkmark From LIBRETTO-001 trial in RET fusion-positive NSCLC
Aug 2020 - Aug 2020: From LIBRETTO-001 trial in RET fusion-positive NSCLC
Checkmark Granted for advanced RET fusion+ve 2L thyroid cancer [LIBRETTO-001]
More
Active, not recruiting
1/2
856
Europe, Canada, Japan, US, RoW
LOXO-292, Selpercatinib, LY3527723
Loxo Oncology, Inc., Eli Lilly and Company
Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor
02/25
02/26
NCT04566393: Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies

Available
N/A
US
Ulixertinib (BVD-523)
xCures, Cancer Commons
Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma, Non Small Cell Lung Cancer, Thyroid Cancer, Bladder Cancer, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Ovarian Cancer, Hepatocellular Carcinoma, Glioblastoma, MAPK Gene Mutation, KRAS Activating Mutation, BRAF Gene Mutation, NRAS Gene Mutation, HRAS Gene Mutation, MEK Mutation, ERK Mutation
 
 
Porte, Paul F La
ARTEST, NCT04869943 / 2021-002176-39: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

Terminated
3
52
Europe, US, RoW
Enobosarm, VERU-024, Exemestane, Mestane
Veru Inc.
Metastatic Breast Cancer
01/24
01/24
COSTAR Lung, NCT04655976 / 2020-003433-37: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

Active, not recruiting
3
758
Europe, Canada, Japan, US, RoW
Cobolimab, Dostarlimab, Docetaxel
GlaxoSmithKline
Lung Cancer, Non-Small Cell
04/25
10/25
eNRGy, NCT02912949 / 2014-003277-42: A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion

Active, not recruiting
2
250
Europe, Canada, Japan, US, RoW
zenocutuzumab (MCLA-128), bispecific, MCLA-128
Merus N.V.
Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion
12/26
12/26
NCT05079360: Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer

Withdrawn
2
200
US
Sabizabulin, Veru-111, Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator, exemestane
Veru Inc.
Metastatic Breast Cancer
03/24
05/24
NCT05588609: Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

Active, not recruiting
2
90
US
Afatinib Oral Tablet, GILOTRIF®, GIOTRIF®, Enzalutamide Pill, XTANDI®, Abiraterone acetate tablets, ZYTIGA®, MCLA-128, Zenocutuzumab
Merus N.V.
NSCLC Harboring NRG1 Fusion, Metastatic Castration-resistant Prostate Cancer
10/25
03/26
1-BETTER, NCT04825288: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Completed
1/2
76
US
XB2001 or Placebo
XBiotech, Inc.
Pancreatic Cancer
10/23
06/24
NCT06322693: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Recruiting
1
475
Europe, US, RoW
TSR-022, Nivolumab, TSR-042, TSR-033, Docetaxel, Pemetrexed, Cisplatin, Carboplatin
GlaxoSmithKline
Neoplasms
08/25
02/27
AMBER, NCT02817633: A Study of TSR-022 in Participants With Advanced Solid Tumors

Hourglass Oct 2019 - Mar 2020 : From AMBER trial
Checkmark From AMBER trial at SITC 2018 [screenshot]
Nov 2018 - Nov 2018: From AMBER trial at SITC 2018 [screenshot]
Checkmark From AMBER trial in combination with TSR-022 at SITC 2018
Nov 2018 - Nov 2018: From AMBER trial in combination with TSR-022 at SITC 2018
Recruiting
1
447
Europe, US, RoW
TSR-022, Nivolumab, TSR-042, TSR-033, Docetaxel, Pemetrexed, Cisplatin, Carboplatin
Tesaro, Inc.
Neoplasms
04/25
04/27
Agajanian, Richy
BRUIN CLL-313, NCT05023980: A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Active, not recruiting
3
250
Europe, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Bendamustine, Treanda, Treakisym, Ribomustin, Levact, Rituximab, Rituxan, MabThera, Truxima, Riabni, Ruxience
Loxo Oncology, Inc., Eli Lilly and Company
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
04/25
08/26
NCT01954992: Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Recruiting
3
480
US
Glufosfamide, Fluorouracil, 5-FU
Eleison Pharmaceuticals LLC.
Metastatic Pancreatic Adenocarcinoma
06/26
12/26
BRUIN-CLL-314, NCT05254743 / 2021-003206-41: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Active, not recruiting
3
650
Europe, Canada, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Ibrutinib
Loxo Oncology, Inc., Eli Lilly and Company
Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
06/25
01/28
KICKSTART, NCT04622007: Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC

Hourglass Jan 2024 - Mar 2024 : Q1'24 - Data from P2b KICKSTARTtrial in combination with Keytruda for PD-L1+ve 1L NSCLC
Active, not recruiting
2
68
US, RoW
Tomivosertib, eFT508, Pembrolizumab, Keytruda®, Pemetrexed, Alimta®
Effector Therapeutics, Medpace, Inc., ICON plc
Non-small Cell Lung Cancer
10/24
12/24
BA3011-002, NCT04681131 / 2022-000135-23: CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC

Active, not recruiting
2
240
Europe, US, RoW
CAB-AXL-ADC, BA3011, PD-1 inhibitor
BioAtla, Inc., BioAtla Inc.
Non-Small-Cell Lung Cancer
08/25
08/25
PRESERVE-001, NCT04140526: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Recruiting
1/2
733
US, RoW
ONC-392, A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc., Pembrolizumab, Keytruda, MK3475, Docetaxel, Taxotere, Docefrez
OncoC4, Inc., National Cancer Institute (NCI)
Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cancer, Ovarian Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreas Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, Adenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma
06/26
12/27
OVATION 2, NCT03393884: Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer

Checkmark Presentation of OVATION 2 data in advanced ovarian cancer
Mar 2021 - Mar 2021: Presentation of OVATION 2 data in advanced ovarian cancer
Active, not recruiting
1/2
130
Canada, US
IMNN-001, Carboplatin, Paclitaxel
Imunon
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
07/24
11/25
BA3021-001, NCT03504488 / 2022-000137-17: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Completed
1/2
132
Europe, US, RoW
CAB-ROR2-ADC, BA3021, PD-1 inhibitor
BioAtla, Inc., BioAtla Inc.
Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer
12/24
12/24
NCT02629692 / 2016-001754-18: Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

Active, not recruiting
1/2
122
Europe, US, RoW
Vodobatinib (K0706) capsules
Sun Pharma Advanced Research Company Limited
Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)
08/26
08/26
2018-523-00US1, NCT03779113: An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma

Active, not recruiting
1
140
Europe, US
HMPL-523
Hutchmed
Non Hodgkin Lymphoma
12/24
01/26
Shum, Merrill
NCT05096403 / 2021-003160-27: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Completed
3
24
Europe, Canada, Japan, US, RoW
Pegcetacoplan, Aspaveli
Swedish Orphan Biovitrum, Swedish Orphan Biovitrum AB
Cold Agglutinin Disease
05/24
09/24
XPORT-MM-031, NCT05028348 / 2021-001691-41: A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

Hourglass Jul 2024 - Dec 2024 : H2'24 - Market entry in Malaysia in combination with bortezomib and dexamethasone for r/r MM
Jul 2024 - Dec 2024: Top-line data from XPORT-MM-031 trial in combination with pomalidomide and dexamethasone for multiple myeloma
Recruiting
3
222
Europe, US
Selinexor, KPT-330, Elotuzumab, Pomalidomide, Dexamethasone Oral
Stichting European Myeloma Network, Karyopharm Therapeutics Inc
Multiple Myeloma
03/26
03/29
NCT04442022 / 2020-000605-84: A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or Without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting
2/3
501
Europe, US, RoW
Selinexor (combination therapy), Placebo matching for Selinexor (combination therapy), Rituximab (combination therapy), Gemcitabine (combination therapy), Dexamethasone (combination therapy), Cisplatin (combination therapy), Selinexor (continuous therapy), Placebo matching for Selinexor (continuous therapy)
Karyopharm Therapeutics Inc
Relapsed/refractory Diffuse Large B-cell Lymphoma
12/24
12/25
NCT05119933: A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

Recruiting
1/2
55
US
YL-15293
Shanghai YingLi Pharmaceutical Co. Ltd., Yingli Pharma US, Inc
Advanced Solid Tumor
06/23
12/23
NCT05267899: A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors

Recruiting
1
24
US
WGI-0301
Zhejiang Haichang Biotech Co., Ltd.
Advanced Solid Tumors
10/24
12/24
AMBER, NCT02817633: A Study of TSR-022 in Participants With Advanced Solid Tumors

Hourglass Oct 2019 - Mar 2020 : From AMBER trial
Checkmark From AMBER trial at SITC 2018 [screenshot]
Nov 2018 - Nov 2018: From AMBER trial at SITC 2018 [screenshot]
Checkmark From AMBER trial in combination with TSR-022 at SITC 2018
Nov 2018 - Nov 2018: From AMBER trial in combination with TSR-022 at SITC 2018
Recruiting
1
447
Europe, US, RoW
TSR-022, Nivolumab, TSR-042, TSR-033, Docetaxel, Pemetrexed, Cisplatin, Carboplatin
Tesaro, Inc.
Neoplasms
04/25
04/27
Bettino, Kristen
KICKSTART, NCT04622007: Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC

Hourglass Jan 2024 - Mar 2024 : Q1'24 - Data from P2b KICKSTARTtrial in combination with Keytruda for PD-L1+ve 1L NSCLC
Active, not recruiting
2
68
US, RoW
Tomivosertib, eFT508, Pembrolizumab, Keytruda®, Pemetrexed, Alimta®
Effector Therapeutics, Medpace, Inc., ICON plc
Non-small Cell Lung Cancer
10/24
12/24
Bettino, Kirsten
ARTEST, NCT04869943 / 2021-002176-39: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

Terminated
3
52
Europe, US, RoW
Enobosarm, VERU-024, Exemestane, Mestane
Veru Inc.
Metastatic Breast Cancer
01/24
01/24
LUNA3, NCT04562766 / 2020-002063-60: Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Active, not recruiting
3
232
Europe, Canada, Japan, US, RoW
Rilzabrutinib, PRN1008, Placebo, PRN1008 Placebo
Principia Biopharma, a Sanofi Company, Principia Biopharma, Inc.
Immune Thrombocytopenia
01/25
08/26
NCT01954992: Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Recruiting
3
480
US
Glufosfamide, Fluorouracil, 5-FU
Eleison Pharmaceuticals LLC.
Metastatic Pancreatic Adenocarcinoma
06/26
12/26
LOTIS 5, NCT04384484 / 2020-000241-14: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Checkmark Safety run-in data from LOTIS-5 trial in combination with rituximab in r/r DLBCL at SOHO 2022
Sep 2022 - Sep 2022: Safety run-in data from LOTIS-5 trial in combination with rituximab in r/r DLBCL at SOHO 2022
Hourglass Sep 2021 - Dec 2021 : Submission for r/r DLBCL
Hourglass Nov 2021 - Dec 2021 : From LOTIS 5 trial in combination with rituximab for DLBCL
Active, not recruiting
3
440
Europe, Canada, Japan, US, RoW
Loncastuximab Tesirine, Zynlonta, ADCT-402, Rituximab, Gemcitabine, Oxaliplatin
ADC Therapeutics S.A., ADC Therapeutics SA
Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
06/25
06/28
NOVA-II, NCT04088318: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients

Active, not recruiting
2
170
US, RoW
OQL011, Vehicle Ointment
OnQuality Pharmaceuticals (USA) LLC
Hand-Foot Skin Reaction (HFSR)
02/24
06/24
NCT05079360: Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer

Withdrawn
2
200
US
Sabizabulin, Veru-111, Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator, exemestane
Veru Inc.
Metastatic Breast Cancer
03/24
05/24
NCT05488873: A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy

Active, not recruiting
2
60
US
WST-057 Active, Active, Placebo
WinSanTor, Inc
Chemotherapy-induced Peripheral Neuropathy
04/26
05/26
NCT05002777 / 2021-001671-16: Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

Hourglass Jul 2024 - Dec 2024 : Data from trial for warm autoimmune hemolytic anemia
Active, not recruiting
2
22
Europe, US, RoW
rilzabrutinib, PRN1008/SAR444671
Sanofi, Sanofi Aventis Recherche et Developpement
Warm Autoimmune Hemolytic Anemia (wAIHA)
05/24
05/25
NCT04984811: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Active, not recruiting
2
83
US
efineptakin alfa, NT-I7, Atezolizumab, Tecentriq
NeoImmuneTech, Roche Pharma AG
Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer
09/24
03/25
BA3011-002, NCT04681131 / 2022-000135-23: CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC

Active, not recruiting
2
240
Europe, US, RoW
CAB-AXL-ADC, BA3011, PD-1 inhibitor
BioAtla, Inc., BioAtla Inc.
Non-Small-Cell Lung Cancer
08/25
08/25
1-BETTER, NCT04825288: XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Completed
1/2
76
US
XB2001 or Placebo
XBiotech, Inc.
Pancreatic Cancer
10/23
06/24
OVATION 2, NCT03393884: Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer

Checkmark Presentation of OVATION 2 data in advanced ovarian cancer
Mar 2021 - Mar 2021: Presentation of OVATION 2 data in advanced ovarian cancer
Active, not recruiting
1/2
130
Canada, US
IMNN-001, Carboplatin, Paclitaxel
Imunon
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
07/24
11/25
OPAL, NCT04329728: The Study: AVM0703 for Treatment of Lymphoid Malignancies

Recruiting
1/2
144
US
AVM0703, Supra-Pharmacologic Dexamethasone Phosphate
AVM Biotechnology Inc, Medpace, Inc.
Lymphoid Malignancies
04/25
06/25
BA3021-001, NCT03504488 / 2022-000137-17: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Completed
1/2
132
Europe, US, RoW
CAB-ROR2-ADC, BA3021, PD-1 inhibitor
BioAtla, Inc., BioAtla Inc.
Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer
12/24
12/24
SGNB6A-001, NCT04389632: A Study of SGN-B6A in Advanced Solid Tumors

Recruiting
1
824
Europe, US, RoW
sigvotatug vedotin, SGN-B6A, pembrolizumab, Keytruda, cisplatin, carboplatin
Seagen Inc.
Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Ovarian Neoplasms, Cutaneous Squamous Cell Cancer, Exocrine Pancreatic Adenocarcinoma, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms
11/26
02/28
I-RUX-15-04, NCT03110822: A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Checkmark Data from I-RUX study for R/R multiple myeloma
Dec 2022 - Dec 2022: Data from I-RUX study for R/R multiple myeloma
Recruiting
1
134
US
Ruxolitinib Oral Tablet [Jakafi], Ruxolitinib, Jakavi, Lenalidomide, Revlimid, Methylprednisolone, Depo-Medrol, Solu-Medrol, Methyl Prednisolonate
Oncotherapeutics, Incyte Corporation
Multiple Myeloma
09/24
02/27
Contact, Site Public
NCT04985682 / 2022-004149-11: A Study of ADVATE in People With Hemophilia A in India

Completed
4
50
RoW
ADVATE
Baxalta now part of Shire, Takeda Development Center Americas, Inc.
Hemophilia A
02/23
02/23
SWITCH, NCT04718779: A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction Therapy

Completed
4
4
US
Digital Engagement Application (GD App), No Intervention
Takeda
Gaucher Disease
02/23
02/23
COMPASS-CD, NCT04809363: A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

Active, not recruiting
4
200
US
CDPATH™, PROSPECT, Blood Draw
Takeda
Crohn's Disease
10/25
06/26
NCT05341115 / 2022-002471-11: A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Recruiting
4
80
RoW
Leuprorelin Acetate Depot 3M, Leuprolide acetate Depot 3M
Takeda, Takeda
Central Precocious Puberty
05/25
05/25
TAK-665-4001, NCT05058391 / 2022-004193-39: A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India

Completed
4
5
RoW
Elaprase, Idursulfase
Takeda, Takeda Biopharmaceuticals India Pvt. Ltd.
Hunter Syndrome
04/24
04/24
NCT05442554: A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma

Completed
4
10
RoW
Brentuximab vedotin, SGN-35
Takeda
T-Cell Lymphoma
08/24
08/24
NCT05067868: A Study of Replagal in Children and Adults With Fabry Disease in India

Active, not recruiting
4
5
RoW
Replagal
Shire
Fabry Disease
10/26
11/26
TAK-113-4002, NCT06562543: A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

Recruiting
4
78
US
Fruquintinib, Fruzaqla™
Takeda
Colorectal Cancer
02/28
02/28
NCT04085172 / 2018-000821-29: A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)

Active, not recruiting
4
288
Europe, US
Guanfacine hydrochloride (TAK-503), Intuniv, SPD503, Atomoxetine hydrochloride, Placebo
Shire, Takeda Development Center Americas, Inc.
Attention Deficit Hyperactivity Disorder
06/27
06/27
ASPIRE, NCT04118088 / 2017-002491-10: A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

Active, not recruiting
4
50
Europe, RoW
Darvadstrocel, Alofisel, Cx601
Takeda, Takeda Development Center Americas, Inc.
Crohn's Disease, Complex Perianal Fistula
03/26
03/26
NCT05494593: A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)

Recruiting
4
5
US
ELAPRASE, Idursulfase, Rituximab, Methotrexate, Intravenous Immunoglobulin (IVIG)
Takeda, Takeda Development Center Americas, Inc.
Mucopolysaccharidosis (MPS), Hunter Syndrome
07/28
07/28
NCT06045754: A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Recruiting
4
150
Canada, US
Vedolizumab, Entyvio, Adalimumab, Humira, Ustekinumab, Stelara
Takeda
Crohn's Disease
06/27
06/27
NCT06095128: A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Recruiting
4
65
Canada, US
Vedolizumab, Entyvio, MLN0002, Tofacitinib, Xeljanz, CP-690, CP-550
Takeda
Ulcerative Colitis
07/27
07/27
PhALLCON, NCT03589326 / 2018-000397-30: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Checkmark Data from PhALLCON Study for newly diagnosed Ph+ ALL at SOHO 2020
Sep 2019 - Sep 2019: Data from PhALLCON Study for newly diagnosed Ph+ ALL at SOHO 2020
Checkmark Initiation of new trial in Ph+ ALL
Jul 2018 - Jul 2018: Initiation of new trial in Ph+ ALL
Active, not recruiting
3
245
Europe, Canada, Japan, US, RoW
Ponatinib, Iclusig, Imatinib, Gleevec, Vincristine, Dexamethasone, Cytarabine, Methotrexate, Prednisone
Takeda
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
08/22
07/27
NCT04840667 / 2018-004689-32: A Study of Replagal in Treatment-naïve Adults With Fabry Disease

Terminated
3
17
Europe, Canada
REPLAGAL, SHP675
Shire
Fabry Disease
12/22
12/22
NCT04444895 / 2019-004823-20: A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Completed
3
73
Europe, Canada, Japan, US
Lanadelumab, DX-2930, SHP643, TAK-743
Shire, Takeda Development Center Americas, Inc.
Angioedema
05/23
05/23
NCT03393975 / 2017-000858-18: A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)

Completed
3
51
Europe, Japan, US
BAX930, rADAMTS13, SHP-655, TAK-755, recombinant ADAMTS13, BAX 930, Standard of care
Baxalta now part of Shire, Takeda Development Center Americas, Inc.
Thrombotic Thrombocytopenic Purpura (TTP)
12/23
05/24
NCT03879135 / 2018-003453-16: A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)

Completed
3
38
Europe, US, RoW
rVWF, Vonvendi, Vonicog alfa, rFVIII, Octocog alfa, ADVATE
Baxalta now part of Shire, Takeda Development Center Americas, Inc.
Von Willebrand Disease (VWD)
01/25
01/25
SKYWAY, NCT04938427 / 2021-002481-40: A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

Completed
3
270
Europe, Canada, Japan, US, RoW
Placebo, Soticlestat, TAK-935
Takeda
Lennox Gastaut Syndrome (LGS)
01/24
01/24
NCT06165341: Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis)

Recruiting
3
50
Europe, Canada, US
Fazirsiran Injection, TAK-999, ARO-AAT, ADS-001, Placebo
Takeda
Alpha1-Antitrypsin Deficiency
08/28
08/28
NCT02932618 / 2016-001477-33: A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)

Recruiting
3
34
Europe, US, RoW
von Willebrand factor (Recombinant), VONVENDI, rVWF, BAX111, BAX 111, Antihemophilic Factor (Recombinant), ADVATE, Recombinant Factor VIII, rFVIII
Baxalta now part of Shire, Takeda Development Center Americas, Inc.
Von Willebrand Disease
01/25
01/25
SKYLINE, NCT04940624 / 2021-002480-22: A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

Completed
3
144
Europe, Canada, Japan, US, RoW
Soticlestat, TAK-935, Placebo
Takeda
Dravet Syndrome (DS)
04/24
04/24
TAK-935-3004, NCT06422377: A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

Terminated
3
1
Europe
Soticlestat, TAK-935
Takeda
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
08/24
08/24
NCT04974749 / 2022-004246-35: A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease

Completed
3
20
RoW
REPLAGAL, Agalsidase Alfa, TAK-675
Takeda, Takeda Development Center Americas, Inc
Fabry Disease
01/24
01/24
NCT05460325 / 2023-001105-31: A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)

Completed
3
20
RoW
Lanadelumab, SHP643, TAKHZYRO, TAK-743, DX-2930, Lanadelumab Injection
Takeda, Takeda
Hereditary Angioedema (HAE)
11/23
11/23
TAK-279-PsO-3003, NCT06550076: A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis

Recruiting
3
1300
Europe, Canada, Japan, US, RoW
TAK-279
Takeda
Plaque Psoriasis
05/26
05/26
Vedolizumab-3041, NCT06443502: A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Recruiting
3
30
Europe, RoW
Vedolizumab, Entyvio, MLN0002, Kynteles, Concomitant Antibiotic Therapy
Takeda
Pouchitis
12/29
12/29
NCT06060067 / 2023-000134-15: A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

Active, not recruiting
3
480
RoW
TDV, TAK-003, Placebo
Takeda, Takeda
Healthy Volunteers
05/25
05/25
NCT04779320 / 2020-004301-31: A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Recruiting
3
120
Europe, Canada, Japan, US, RoW
Vedolizumab IV, ENTYVIO, KYNTELES, MLN0002
Takeda, Takeda Development Center Americas, Inc.
Crohn's Disease (CD)
11/24
11/24
NCT05529992 / 2022-002323-35: A Study of Velaglucerase Alfa (VPRIV) in Chinese Children, Teenagers, and Adults With Type 1 Gaucher Disease

Completed
3
20
RoW
Velaglucerase Alfa, VPRIV
Takeda, Takeda
Gaucher Disease
08/24
08/24
NCT05707351: A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

Completed
3
37
RoW
Adynovate, Antihemophilic Factor (recombinant) PEGylated, Rurioctocog Alfa Pegol
Takeda
Hemophilia A
09/24
09/24
VICTRIVA, NCT06227910: A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Recruiting
3
396
Canada, US
Vedolizumab, Entyvio, MLN0002, KYNTELES, Upadacitinib, Rinvoq, Placebo
Takeda
Crohn's Disease
06/27
08/28
NCT06439342: A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

Not yet recruiting
3
20
RoW
Maribavir, TAK-620
Takeda
Cytomegalovirus (CMV)
02/27
02/27
SWOG S2302, NCT05633602: Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

Recruiting
3
700
US
Chemotherapy, Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Ramucirumab, Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806
SWOG Cancer Research Network, National Cancer Institute (NCI), Eli Lilly and Company, Merck Sharp & Dohme LLC
Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
03/25
03/28
NCT04701411 / 2020-003193-48: A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease

Recruiting
3
20
Europe, Japan, RoW
Darvadstrocel, Cx601
Takeda, Takeda Development Center Americas, Inc.
Crohn's Disease, Complex Perianal Fistula
06/25
12/25
ACTION-1, NCT05477576 / 2022-000507-12: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Recruiting
3
288
Europe, Canada, US, RoW
RYZ101, Everolimus, Sunitinib, Octreotide, Lanreotide
RayzeBio, Inc., RayzeBio, Inc.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET
12/25
07/28
TAK-279-3002, NCT06108544: A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

Active, not recruiting
3
1108
Europe, Canada, US, RoW
TAK-279, Placebo, Apremilast
Takeda
Plaque Psoriasis
12/24
11/25
NCT06088043: A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment

Active, not recruiting
3
693
Europe, Canada, Japan, US, RoW
TAK-279, Placebo, Apremilast
Takeda
Plaque Psoriasis
08/25
04/26
MLN0002-3024, NCT04779307 / 2020-004300-34: A Study of Vedolizumab in Children and Teenagers with Moderate to Severe Ulcerative Colitis (UC)

Active, not recruiting
3
121
Europe, Canada, Japan, US, RoW
Vedolizumab, MLN0002, ENTYVIO, KYNTELES
Takeda, Takeda Development Center Americas, Inc.
Colitis, Ulcerative
08/25
08/25
NCT04759833 / 2022-003221-22: A Study of Prucalopride For Functional Constipation in Children and Teenagers

Terminated
3
175
US
Prucalopride, TAK-555, Prucalopride succinate, Placebo
Takeda, Takeda Development Center Americas, Inc.
Constipation
11/23
11/23
NCT05156983 / 2021-004138-12: A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

Recruiting
3
328
Europe, Canada, US
TAK-330, SOC 4F-PCC
Takeda, Takeda Development Center Americas, Inc.
Coagulation Disorder
04/28
04/28
ENDYMION 2, NCT05163314 / 2021-002482-17: A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Recruiting
3
400
Europe, Canada, Japan, US, RoW
Soticlestat, TAK-935
Takeda
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
05/26
05/26
NCT04683003: A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura

Recruiting
3
77
Europe, Japan, US, RoW
TAK-755, rADAMTS13; recombinant ADAMTS13; SHP-655; BAX 930
Takeda, Takeda Development Center Americas, Inc., Shire
Thrombotic Thrombocytopenic Purpura (TTP)
03/27
03/27
TAK-620-2004, NCT05319353 / 2021-004279-15: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

Active, not recruiting
3
80
Europe, Japan, US, RoW
Maribavir, TAK-620
Takeda, Takeda Development Center Americas, Inc.
Cytomegalovirus (CMV)
01/27
01/27
NCT04969731: Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer

Recruiting
3
408
RoW
Immuncell-LC, Autologous activated T lymphocyte, Gemcitabine
GC Cell Corporation
Pancreatic Ductal Adenocarcinoma
12/26
06/27
PACES, NCT01349881: S0820, Adenoma and Second Primary Prevention Trial

Active, not recruiting
3
354
US
Eflornithine placebo & sulindac placebo, eflornithine & sulindac placebo, Eflornithine placebo & sulindac, Eflornithine plus sulindac
SWOG Cancer Research Network, National Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.
Colorectal Neoplasms
02/27
02/32
NCT05582993 / 2020-003304-13: A Study of Recombinant Von Willebrand Factor (rVWF) (TAK-577) in Children With Severe Von Willebrand Disease (vWD)

Recruiting
3
24
Europe, US
Recombinant von Willebrand Factor (rVWF), TAK-577, Vonicog Alfa, ADVATE, Recombinant Factor VIII (rFVIII), Octocog Alfa
Takeda, Takeda Development Center Americas, Inc.
Von Willebrand Disease (VWD)
04/30
04/30
NCT05677971: Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Recruiting
3
160
Europe, Canada, US, RoW
Fazirsiran Injection, TAK-999, ARO-AAT, ADS-001, Placebo, Sodium chloride
Takeda, Takeda Development Center Americas, Inc.
Alpha1-Antitrypsin Deficiency
03/27
03/29
TAK-881-3002, NCT06076642: A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

Recruiting
3
39
US
TAK-881, Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)., SC Investigational Needle Sets
Takeda, Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda
Primary Immunodeficiency Diseases (PID)
01/29
01/29
CompassHER2 RD, NCT04457596: T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the Trial

Calendar Jan 2028 - Dec 2028: From CompassHER2 RD trial in combination with Kadcyla for HER2+ breast cancer
Recruiting
3
1031
Canada, US
Trastuzumab Emtansine, Placebo Administration, Tucatinib, Questionnaire Administration, Quality-of-Life Assessment
Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI), Seagen Inc.
Anatomic Stage IA Breast Cancer AJCC V8, Anatomic Stage II Breast Cancer AJCC V8, Anatomic Stage IIA Breast Cancer AJCC V8, Anatomic Stage IIB Breast Cancer AJCC V8, Anatomic Stage III Breast Cancer AJCC V8, Anatomic Stage IIIA Breast Cancer AJCC V8, Anatomic Stage IIIB Breast Cancer AJCC V8, Anatomic Stage IIIC Breast Cancer AJCC V8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC V8, Prognostic Stage IA Breast Cancer AJCC V8, Prognostic Stage IB Breast Cancer AJCC V8, Prognostic Stage II Breast Cancer AJCC V8, Prognostic Stage IIA Breast Cancer AJCC V8, Prognostic Stage IIB Breast Cancer AJCC V8, Prognostic Stage III Breast Cancer AJCC V8, Prognostic Stage IIIA Breast Cancer AJCC V8, Prognostic Stage IIIB Breast Cancer AJCC V8, Prognostic Stage IIIC Breast Cancer AJCC V8, Synchronous Bilateral Breast Carcinoma
01/28
05/35
NCT03221036: Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

Recruiting
3
402
RoW
Vedolizumab IV, Placebo
Takeda
Moderately to Severely Active Ulcerative Colitis
05/28
07/28
DRAMMATIC, NCT04071457: S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

Hourglass Jan 2023 - Jun 2023 : From trial for patients with r/r multiple myeloma treated with an IMiD and PI
Recruiting
3
1100
Canada, US
Lenalidomide, CC-5013, Revlimid, Daratumumab/rHuPH20
SWOG Cancer Research Network, National Cancer Institute (NCI), Janssen, LP
Multiple Myeloma
07/29
07/40
NCT05837897: A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

Recruiting
3
408
RoW
Vedolizumab IV, Placebo
Takeda
Crohn's Disease
03/30
05/31
NCT05442567 / 2021-000630-34: A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Recruiting
3
240
Europe, Canada, Japan, US, RoW
Vedolizumab IV, MLN0002, ENTYVIO, KYNTELES, No Intervention
Takeda, Takeda Development Center Americas, Inc.
Ulcerative Colitis, Crohn's Disease
08/31
08/31
NCT05755035: A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

Recruiting
2/3
75
Europe, US, RoW
TAK-881, Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)., HYQVIA, Immune Globulin Infusion (Human), 10% Solution with rHuPH20.
Takeda, Takeda Development Center Americas, Inc.
Primary Immunodeficiency Diseases (PID)
02/26
09/26
 

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