A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Phase 1

Active, not recruiting

• Conditions: Advanced Malignancies That Harbor IDHR132 Mutations
• Interventions: Drug: IDH305

• Registration Number: NCT02381886
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-02
• Study Start: 2015-03-06
• Study First Posted: 2015-03-06
• Primary Completion: 2016-12-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDH305	IDH305	-

Primary Outcome Measures

Name	Time	Method
Incident rate of dose limiting toxicities (DLTs)	21 days	To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	30 months	To characterize the safety and tolerability of IDH305
Incidence of serious adverse events (SAE)	30 months	To characterize the safety and tolerability of IDH305
Plasma PK parameters (AUC, Cmax, Tmax)	30 months	To characterize the PK profile of IDH305
Changes of 2-hydroxyglutarate concentration in patient specimens	30 months	To characterize the PD profile of IDH305
Overall response rate (ORR)	30 months	To assess any preliminary anti-tumor activity of IDH305

Trial Locations

Locations (5)

Uni Of TX MD Anderson Cancer Cntr; 🇺🇸 Houston, Texas, United States

Dana Farber Cancer Institute SC (1); 🇺🇸 Boston, Massachusetts, United States

Columbia University Medical Center- New York Presbyterian Onc Dept.; 🇺🇸 New York, New York, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Catalunya, Spain

ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55; 🇳🇱 Rotterdam, Netherlands