HMPL-306 for Isocitrate Dehydrogenase Deficiency
Recruiting at10 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Hutchison Medipharma Limited
No Placebo Group
Trial Summary
What is the purpose of this trial?
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
Research Team
BZ
Bo Zhang
Principal Investigator
Hutchison Medipharma Limited
Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors that have an IDH mutation and have worsened despite standard treatments. Participants must be in fairly good physical condition (ECOG status 0 or 1) and cannot be pregnant, breastfeeding, or have severe infections, certain heart conditions, life-threatening complications of leukemia, specific gastrointestinal or liver diseases, or inadequate organ function.Inclusion Criteria
My cancer has returned or worsened after standard treatment and cannot be cured.
I am fully active or can carry out light work.
My cancer has an IDH mutation confirmed by a lab test.
See 1 more
Exclusion Criteria
I do not have a severe infection or unexplained fever over 38.3°C.
I have or had liver or gastrointestinal diseases.
Subjects who received an investigational agent <14 days prior to their first day of study drug administration
See 5 more
Treatment Details
Interventions
- HMPL-306 (IDH Inhibitor)
Trial OverviewThe study is testing HMPL-306's safety and effectiveness on patients with IDH-mutated advanced solid tumors. It's an open-label trial meaning everyone knows what treatment they're getting. Researchers will look at how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and any signs of tumor shrinkage.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2 Dose Expansion CohortsExperimental Treatment1 Intervention
Patients from each cohort will be administered HMPL-306 orally QD at the recommended phase 2 dose
Group II: Part 1 Dose Escalation CohortsExperimental Treatment1 Intervention
Patients from each cohort will be administered HMPL-306 orally QD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hutchison Medipharma Limited
Lead Sponsor
Trials
104
Recruited
14,000+
Dr. Weiguo Su
Hutchison Medipharma Limited
Chief Executive Officer since 2022
PhD in Chemistry from Harvard University, BSc in Chemistry from Fudan University
Dr. Karen Atkin
Hutchison Medipharma Limited
Chief Medical Officer since 2023
MD from Harvard Medical School
Hutchmed
Lead Sponsor
Trials
38
Recruited
6,700+