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HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
Sponsor: Hutchmed
Summary
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying IDH1 or IDH2 mutations.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2026-11
Completion Date
2032-09
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
HMPL-306 tablet
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Placebo
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.