HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors
Hutchmed
186 participants
Mar 4, 2026
INTERVENTIONAL
Conditions
Summary
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
Eligibility
Inclusion Criteria6
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Exclusion Criteria8
- An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- Participant has received a live within 3 months before study enrollment
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A580
- Pregnant (positive pregnancy test) or lactating;
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Interventions
Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.
Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07396584