Clinical trials: Isocitrate Dehydrogenase Gene Mutation
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
- Trial name
- NCT04762602
- Testing
- HMPL-306
- Where
- 11 sites in United States, Spain
- Volunteers
- 42 people
- Sponsor
- Hutchmed
Biliary Carcinoma
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint.
- Trial name
- NCT05987358
- Testing
- TQB3454 tablets
- Where
- 6 sites in China
- Volunteers
- 165 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH…
- Trial name
- NCT04764474
- Testing
- HMPL-306
- Where
- 15 sites in United States, Spain
- Volunteers
- 46 people
- Sponsor
- Hutchmed
Hematologic Neoplasms
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle…
- Trial name
- NCT01915498
- Testing
- Enasidenib
- Where
- 24 sites in United States, France
- Volunteers
- 345 people
- Sponsor
- Celgene
NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic
First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor
This is a phase 1, multicentre, first-in-human, open-label, dose-escalation/consolidation study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered JBI-778 in EGFR mutated…
- Conditions
- NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic, Adenoid Cystic Carcinoma of the Head and Neck
- Trial name
- NCT07755397
- Testing
- JBI-778
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Jubilant Therapeutics India Limited
Leukemia, Myeloid, Acute
A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy
The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2.
- Trial name
- NCT02677922
- Testing
- AG-120, Azacitidine, AG-221
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 130 people
- Sponsor
- Celgene
Solid Tumors, Triple-Negative Breast Cancer
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival.
- Conditions
- Solid Tumors, Triple-Negative Breast Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma
- Trial name
- NCT02071862
- Testing
- CB-839, Pac-CB, CBE
- Where
- 13 sites in United States
- Volunteers
- 210 people
- Sponsor
- Calithera Biosciences, Inc
Leukemia, Myeloid, Isocitrate Dehydrogenase
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML)…
- Trial name
- IDHENTIFY (NCT02577406)
- Testing
- AG-221, BSC, Azacitidine
- Where
- 93 sites in United States, Australia and 16 more
- Volunteers
- 319 people
- Sponsor
- Celgene
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or…
- Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- Trial name
- NCT07712757
- Testing
- Safusidenib
- Volunteers
- 140 people
- Sponsor
- Nuvation Bio Inc.