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RecruitingPhase 1NCT07025018

Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations

A Multicenter, Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HMPL-306 in Patients With Gliomas Harboring IDH1 and/or IDH2 Mutations

Sponsor

Hutchmed

Enrollment

52 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Gliomas Harboring IDH1 and/or IDH2 Mutations

Summary

This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Fully informed about the study and voluntarily sign the informed consent form (ICF).
  • Age ≥ 18 years.
  • Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and/or IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and/or IDH2 mutations scheduled for surgery.
  • All patients must have at least one measurable lesion.
  • Karnofsky Performance Status (KPS) score ≥ 80% .
  • In the investigator's judgment, a life expectancy of ≥ 12 weeks.
  • Sufficient bone marrow and organ function.

Exclusion Criteria9

  • Previous treatment with IDH inhibitors.
  • Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).
  • Patients assessed by researchers to have high-risk or unstable conditions.
  • Having other malignancies or a history of other malignancies within 5 years prior to screening.
  • History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.
  • Patients with HIV infection.
  • Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.
  • Presence of diseases or conditions affecting drug absorption.
  • Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.

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Interventions

DRUGHMPL-306

IDH small molecule inhibitor

Locations(1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

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NCT07025018