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8 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
aldoxorubicin (INNO-206) / LadRx
QUILT-88, NCT04390399: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Checkmark Data from QUILT 88 trial in combination anti–PD-L1 NK cell therapy in advanced pancreatic cancer at ASCO 2022
Jun 2022 - Jun 2022: Data from QUILT 88 trial in combination anti–PD-L1 NK cell therapy in advanced pancreatic cancer at ASCO 2022
Hourglass Jul 2021 - Sep 2021 : Anticipated enrollment of Cohort C in metastatic 3L pancreatic cancer
Active, not recruiting
2
328
US
N-803, Aldoxorubicin HCl, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine, Cyclophosphamide, 5-Fluorouracil, Leucovorin, SBRT, Irinotecan liposome
ImmunityBio, Inc.
Pancreatic Cancer
10/25
10/25
QUILT-3.071, NCT03563157: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

Terminated
1/2
2
US
Aldoxorubicin Hydrochloride, ALT-803, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT
ImmunityBio, Inc.
Colorectal Cancer Metastatic, mCRC
04/19
08/19
QUILT-3.067, NCT03387085: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

Terminated
1/2
9
US
Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK for Infusion, avelumab, bevacizumab, Capecitabine, Cisplatin, Cyclophosphamide, 5-Fluorouracil, Leucovorin, nab-Paclitaxel, SBRT
ImmunityBio, Inc.
Triple Negative Breast Cancer
09/20
01/24
NCT02570412: Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

No Longer Available
N/A
US
aldoxorubicin
CytRx
Sarcoma
 
 
Miplyffa (arimoclomol) / Orphazyme, Zevra Therap
2019-000749-11: An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial

Not yet recruiting
3
130
Europe
Arimoclomol, BRX-345, Capsule, hard
Orphazyme A/S, Orphazyme A/S
Sporadic Inclusion Body Myositis (sIBM), progressive weakening of the muscles, Body processes [G] - Metabolic Phenomena [G03]
 
 
2015-004438-93: A clinical study to investigate the study drug Arimoclomol in a double blind, randomised, placebo-controlled study in patients diagnosed with Niemann Pick disease type C.

Ongoing
2/3
57
Europe, RoW
Arimoclomol, _, Capsule, hard
Orphazyme A/S, Orphazyme ApS, Orphazyme A/S, Orphazyme ApS
Niemann Pick disease type C, Niemann-Pick Type C is a rare and inherited disease in which quantities of fatty substances accumulate in the brain and other organs. The brain, central nervous system, liver and spleen are affected., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
2017-004903-33: Study of Arimoclomol in patients with Inclusion Body Myositis (IBM)

Not yet recruiting
2/3
150
Europe
Arimoclomol, BRX-345, Capsule, hard
Orphazyme A/S, Orphazyme A/S
Sporadic Inclusion Body Myositis (sIBM), progressive weakening of the muscles, Body processes [G] - Metabolic Phenomena [G03]
 
 
2008-008208-42: A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis

Ongoing
2
12
Europe
Arimoclomol, BRX-345,
UCL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit
The research project proposes to investigate Sporadic Inclusion Body Myositis (IBM).IBM is the commonest acquired disease of muscle affecting people aged 50 years and over. It is a progressive and debilitating disease which causes both muscle weakness and wasting, characteristically of the quadriceps and finger flexors. Over time it can lead to severe disability, falls and swallowing impairment. IBM is currently without a clinically proven, effective pharmacological treatment.
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
aldoxorubicin (INNO-206) / LadRx
QUILT-88, NCT04390399: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Checkmark Data from QUILT 88 trial in combination anti–PD-L1 NK cell therapy in advanced pancreatic cancer at ASCO 2022
Jun 2022 - Jun 2022: Data from QUILT 88 trial in combination anti–PD-L1 NK cell therapy in advanced pancreatic cancer at ASCO 2022
Hourglass Jul 2021 - Sep 2021 : Anticipated enrollment of Cohort C in metastatic 3L pancreatic cancer
Active, not recruiting
2
328
US
N-803, Aldoxorubicin HCl, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine, Cyclophosphamide, 5-Fluorouracil, Leucovorin, SBRT, Irinotecan liposome
ImmunityBio, Inc.
Pancreatic Cancer
10/25
10/25
QUILT-3.071, NCT03563157: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

Terminated
1/2
2
US
Aldoxorubicin Hydrochloride, ALT-803, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT
ImmunityBio, Inc.
Colorectal Cancer Metastatic, mCRC
04/19
08/19
QUILT-3.067, NCT03387085: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

Terminated
1/2
9
US
Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK for Infusion, avelumab, bevacizumab, Capecitabine, Cisplatin, Cyclophosphamide, 5-Fluorouracil, Leucovorin, nab-Paclitaxel, SBRT
ImmunityBio, Inc.
Triple Negative Breast Cancer
09/20
01/24
NCT02570412: Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

No Longer Available
N/A
US
aldoxorubicin
CytRx
Sarcoma
 
 
Miplyffa (arimoclomol) / Orphazyme, Zevra Therap
2019-000749-11: An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial

Not yet recruiting
3
130
Europe
Arimoclomol, BRX-345, Capsule, hard
Orphazyme A/S, Orphazyme A/S
Sporadic Inclusion Body Myositis (sIBM), progressive weakening of the muscles, Body processes [G] - Metabolic Phenomena [G03]
 
 
2015-004438-93: A clinical study to investigate the study drug Arimoclomol in a double blind, randomised, placebo-controlled study in patients diagnosed with Niemann Pick disease type C.

Ongoing
2/3
57
Europe, RoW
Arimoclomol, _, Capsule, hard
Orphazyme A/S, Orphazyme ApS, Orphazyme A/S, Orphazyme ApS
Niemann Pick disease type C, Niemann-Pick Type C is a rare and inherited disease in which quantities of fatty substances accumulate in the brain and other organs. The brain, central nervous system, liver and spleen are affected., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
2017-004903-33: Study of Arimoclomol in patients with Inclusion Body Myositis (IBM)

Not yet recruiting
2/3
150
Europe
Arimoclomol, BRX-345, Capsule, hard
Orphazyme A/S, Orphazyme A/S
Sporadic Inclusion Body Myositis (sIBM), progressive weakening of the muscles, Body processes [G] - Metabolic Phenomena [G03]
 
 
2008-008208-42: A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis

Ongoing
2
12
Europe
Arimoclomol, BRX-345,
UCL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit
The research project proposes to investigate Sporadic Inclusion Body Myositis (IBM).IBM is the commonest acquired disease of muscle affecting people aged 50 years and over. It is a progressive and debilitating disease which causes both muscle weakness and wasting, characteristically of the quadriceps and finger flexors. Over time it can lead to severe disability, falls and swallowing impairment. IBM is currently without a clinically proven, effective pharmacological treatment.
 
 

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