Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HMPL-306
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov