Approval Probability
TA Base Rate
Adjusted LOA
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IDH305 · 1 trial · 1 indication
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
| Arm | Type | Description |
|---|---|---|
| IDH305 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IDH305 | DRUG | - |
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 ...
IDH305 is an investigational therapy being studied in adults with advanced malignancies that harbor IDH1 R132 mutations. It is being evaluated in a Phase 1 trial in patients with these biomarker-selected solid and hematologic cancers. It is not approved for any indication.
IDH305 targets mutant IDH1, the isocitrate dehydrogenase 1 enzyme. It is a small-molecule IDH1 inhibitor designed to act on cancers carrying IDH1 R132 mutations. By inhibiting the mutant enzyme, the drug aims to interfere with the altered metabolic pathway driving these tumors.
IDH305 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the compound in IDH1-mutant advanced malignancies.
IDH305 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 study is currently active but not recruiting participants.
IDH305 is being studied in the Phase 1 trial NCT02381886, titled A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations. The trial has enrolled 166 patients across the United States, Australia, Belgium, Canada, Germany, Netherlands, Singapore, and Spain, and is active but not recruiting.