RecruitingPhase 1NCT07006688

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

Sponsor

Servier Bio-Innovation LLC

Enrollment

30 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

IDH1-Mutated Malignancies

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an IDH1 mutation inhibitor drug in patients with IDH1-mutated blood cancers or solid tumors who also have liver or kidney impairment. The goal is to understand how the drug behaves in the body when liver or kidney function is reduced, to help determine safe dosing for these patients. **You may be eligible if...** - You are 18 years or older - You have a confirmed IDH1 R132 mutation in a blood cancer (such as AML, MDS, MPN, lymphoma, or multiple myeloma) or a solid tumor (not glioma) - You have moderate or severe liver impairment, OR severe kidney impairment, OR you have normal organ function (to serve as a comparison group) **You may NOT be eligible if...** - Your IDH1 mutation is in a glioma (brain tumor) - Your organ function does not fall into one of the defined study groups - You do not consent to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib Oral Tablet

500mg Ivosidenib taken orally once daily for continuous 28-day cycles

Locations(19)

Emory University

Atlanta, Georgia, United States

MD Anderson

Houston, Texas, United States

Icon Cancer Centre

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Fakultni nemocnice v Motole FN Motol

Prague, HlavnÃ- Mesto Praha, Czechia

University Hospital Brno

Brno, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severence Hospital, Yonsei University Health Systems

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

START - Hospital HM Nou Delfos

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

START Madrid - Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START Madrid Centro Oncologico Clara Campal Sanchinarro Univesrity Hospital

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07006688

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