A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
ConditionHematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 132 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 72 patients in the dose expansion phase.
Eligibility criteria
Qualifiers
Subjects must meet all of the following criteria to be eligible for enrolment.
Having understood this study adequately and being voluntary to sign the ICF;
Age ≥18 years;
1) Dose escalation phase: patient with MLL-rearranged and/or NPM1-mutant relapsed/refractory AML or ALL (confirmed as per the 2022 World Health Organization (WHO) Classification of Myeloid Neoplasms and Acute Leukemia): 2) Dose expansion phase: approximately 10 to 20 patients will be enrolled in each of the following cohorts
Disqualifiers
Patients who have previously received treatment with menin inhibitors and experienced progression during treatment;
Patients with definite active central nervous system (CNS) leukemia (prior CNS leukemia has been treated and controlled, but a cerebrospinal fluid test through lumbar puncture is required at screening to confirm the absence of CNS involvement);
ALT or AST > 3 × ULN in the absence of liver involvement with leukemia or ALT or AST > 5 × ULN in the presence of liver involvement with leukemia (the latter criterion is not applicable in the dose escalation phase);
Glomerular filtration rate or creatinine clearance estimated using Cockcroft-Gault formula < 50 mL/min.
Trial design
Treatments tested in this trial
- HMPL-506
Treatment groups
132 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov