Actively Recruiting
A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HMPL-506 in Patients With Hematological Malignancies
Led by Hutchmed · Updated on 2025-09-29
132
Participants Needed
16
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label, multicenter clinical study to evaluate the safety, pharmacokinetics, and preliminary efficacy of HMPL-506 in patients with hematological malignancies. The study focuses on patients with specific genetic alterations in blood cancers, including relapsed or refractory Acute Myeloid Leukemia AML, Acute Lymphocytic Leukemia ALL, and multiple myeloma MM. The trial is sponsored by Hutchmed and aims to enroll between 60 and 132 patients across two phases dose escalation and dose expansion. In the dose escalation phase, approximately 30 to 38 patients with MLL-rearranged andor NPM1-mutant relapsedrefractory AML or ALL will receive escalating oral doses of HMPL-506 once daily. Starting at 50 mg, doses may increase based on safety, efficacy, and pharmacokinetic data, with adjustments guided by a Safety Monitoring Committee. The dose expansion phase will enroll about 30 to 60 patients divided into three cohorts based on specific genetic markers or disease type. Patients in this phase will receive the recommended phase 2 dose in 28-day cycles until disease progression, unacceptable toxicity, or other study endpoints. Participants will undergo regular assessments including bone marrow aspiration and biopsy, safety monitoring for dose-limiting toxicities and adverse events, and evaluations of anti-tumor efficacy every treatment cycle. Pharmacokinetic and pharmacodynamic analyses will be conducted, along with electrocardiograms and laboratory tests. Safety follow-up will continue up to 42 months after the last dose. The study includes monitoring for serious adverse events and overall survival, with participants remaining under medical supervision throughout the trial duration.
CONDITIONS
Brief Title
A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide signed informed consent.
- Age 18 years or older.
- Diagnosed with relapsed or refractory AML or ALL with MLL-rearranged and/or NPM1-mutant markers for dose escalation phase.
- For dose expansion phase, diagnosed with relapsed or refractory AML, ALL, or multiple myeloma with specific genetic alterations as defined.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Agree to undergo bone marrow aspiration and/or biopsy before and during treatment.
- Women of childbearing potential must agree to use effective contraception during the study and 30 days afterward; male partners must use condoms during and 30 days after.
- Male patients with female partners of childbearing potential must use condoms during the study and 30 days after and avoid sperm donation during this time.
You will not qualify if you...
- Previous treatment with menin inhibitors resulting in disease progression.
- Active central nervous system leukemia.
- Serum total bilirubin over 1.5 times upper limit of normal except for Gilbert's disease with specific conditions.
- Elevated liver enzymes beyond specified limits.
- Reduced kidney function with creatinine clearance below 50 mL/min.
- Elevated coagulation times unless on anticoagulant therapy.
- Known significant liver diseases including certain hepatitis infections unless viral tests are negative.
- Known HIV infection.
- Pregnant or breastfeeding women.
- History of stroke or brain bleeding within 6 months.
- Other active cancers within 5 years except certain treated non-invasive tumors.
- Significant heart rhythm abnormalities or heart diseases as specified.
- Recent systemic anti-tumor therapy or radiotherapy within 2 weeks with some exceptions.
- Recent hematopoietic stem cell transplant or ongoing immunosuppressive therapy related to transplant with exceptions.
- Recent use of herbal or traditional anti-tumor medicines within 1 week.
- Recent use of strong CYP3A4 inducers or inhibitors before treatment.
- Recent participation in other drug trials with short intervals before this study.
- Major surgery within 4 weeks prior to treatment.
- Unresolved toxicities from prior treatments above grade 1 (except hair loss).
- Active infections requiring hospitalization or intravenous antibiotics.
- Conditions affecting drug absorption or inability to take oral medications.
- Poor compliance or other significant medical conditions that pose risk or affect study results.
Research Team
E
Erin Lou, Doctor
P
Panfeng Tan, Doctor
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