NCT07006688

A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Servier Bio-Innovation LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.

Conditions

• IDH1-Mutated Malignancies

Interventions

Type	Name	Description
DRUG	Ivosidenib Oral Tablet	500mg Ivosidenib taken orally once daily for continuous 28-day cycles

Timeline

• Start date: 2026-01-14
• Primary completion: 2028-07-31
• Completion: 2028-08-31
• First posted: 2025-06-05
• Last updated: 2026-04-06

Locations

19 sites across 6 countries: United States, Australia, Brazil, Czechia, South Korea, Spain

Regulatory

• FDA-regulated drug study