Clinical trial · Interventional
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
NCT02381886CI-TRIAL-00107826active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies That Harbor IDHR132 Mutations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDH305 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IDH305
- interventionNames
- Drug: IDH305
Primary outcomes (1)
- measure
- Incident rate of dose limiting toxicities (DLTs)
- timeFrame
- 21 days
- description
- To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Secondary outcomes (5)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- 30 months
- description
- To characterize the safety and tolerability of IDH305
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Documented IDH1R132-mutant tumors * ECOG performance status ≤ 2 Exclusion Criteria: * Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients) * Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease. * Acute Promyelocytic Leukemia * Women who are pregnant or lactating Other protocol-defined Inclusion/Exclusion may apply
References
Publications (1)
- DERIVEDDiNardo CD, Hochhaus A, Frattini MG, Yee K, Zander T, Kramer A, Chen X, Ji Y, Parikh NS, Choi J, Wei AH. A phase 1 study of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia or myelodysplastic syndrome. J Cancer Res Clin Oncol. 2023 Mar;149(3):1145-1158. doi: 10.1007/s00432-022-03983-6. Epub 2022 Mar 30. PMID 35353219