The Oncology Institute (TOI)
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 2 Trials 
27 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
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 Nov 2021 - Dec 2021 : From LOTIS 5 trial in combination with rituximab for DLBCL
Hourglass Sep 2021 - Dec 2021 : Submission for r/r 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Withdrawn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
Marathe, Omkar
BRUIN-MCL-321, NCT04662255 / 2020-004553-72: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting
3
500
Europe, Canada, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Ibrutinib, Imbruvica, Acalabrutinib, Calquence, Zanubrutinib, Brukinsa
Loxo Oncology, Inc., Eli Lilly and Company
Lymphoma, Mantle-Cell
12/25
07/26
SYMPHONY-1, NCT04224493 / 2019-003333-42: A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

Jan 2023 - Dec 2023: DOR/PFS data from P1b portion of P1b/3 SYMPHONY-1 trial in combination with Revlimid and Rituxan for relapsed/refractory follicular lymphoma
Hourglass Jan 2023 - Dec 2023 : First interim futility data from P3 portion of P1b/3 SYMPHONY-1 trial in combination with Rituxan for relapsed/refractory follicular lymphoma
Hourglass Jan 2022 - Dec 2022 : Completion of enrollment of P3 portion of P1b/3 trial for r/r follicular lymphoma
Checkmark Data from SYMPHONY-1 trial in combination with Rituxan and Revlimid for follicular lymphoma
Jun 2022 - Jun 2022: Data from SYMPHONY-1 trial in combination with Rituxan and Revlimid for follicular lymphoma
More
Recruiting
3
612
Europe, Canada, US, RoW
Tazemetostat, EPZ-6438, IPN60200, Placebo oral tablet, Lenalidomide, Rituximab
Epizyme, Inc.
Relapsed/Refractory Follicular Lymphoma, Follicular Lymphoma, Refractory Follicular Lymphoma
03/26
03/29
PRESERVE-003, NCT05671510: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Active, not recruiting
3
600
Europe, Canada, US, RoW
Gotistobart, A humanized anti-CTLA4 IgG1 monoclonal antibody, ONC-392, BNT316, Docetaxel, Docefrez, Taxotere
OncoC4, Inc., BioNTech SE
Non Small Cell Lung Cancer
06/26
06/27
AIPAC-003, NCT05747794 / 2022-003323-17: Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy

Active, not recruiting
2/3
849
Europe, US, RoW
eftilagimod alpha, IMP321, efti, LAG-3Ig, eftilagimod alfa, Paclitaxel, placebo, placebo matching eftilagimod alpha
Immutep S.A.S., Immutep S.A.S.
Breast Carcinoma
10/26
07/27
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
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
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
C-PRECISE-01, NCT04495621 / 2019-003727-38: MEN1611 With Cetuximab in Metastatic Colorectal Cancer

Completed
1/2
29
Europe, US
MEN1611, Cetuximab
Menarini Group, Menarini Ricerche S.p.A.
Metastatic Colorectal Cancer
01/24
02/24
NCT05438329: First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

Recruiting
1/2
902
US, RoW
DB-1305/BNT325, DB-1305/BNT325 for Injection, Pembrolizumab, BNT327
DualityBio Inc., BioNTech SE
Advanced Solid Tumor
06/25
06/25
RGX-202-001, NCT03597581: A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer

Recruiting
1
108
US
ompenaclid, RGX-202-01, FOLFIRI, Bevacizumab, FOLFOX regimen
Inspirna, Inc.
Gastrointestinal Cancer, Gastrointestinal Neoplasms, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Gastric Cancer, Gastric Neoplasm, KRAS Mutation-Related Tumors, CRC, Colorectal Cancer Metastatic
12/24
12/24
NCT03972527: Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Completed
N/A
85
US
Photobiomodulation, low-level laser therapy, Routine Oral Care and Analgesia, Pain medication, oral rinses
MuReva Phototherapy Inc.
Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Head and Neck Cancer
06/24
07/24

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