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HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
RecruitingPhase 1/2
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Understood this study and are able to voluntarily sign the informed consent form (ICF); 2. Male or Female, Age ≥ 18 years; 3. Histological confirmed, unresectable, advanced or metastatic solid tumor 4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 5. Life expectancy ≥ 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 Exclusion Criteria: 1. An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus 2. 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 3. Major surgery within 28 days prior to the first dose of study drug 4. Active infection requiring systemic treatment 5. Participant has received a live within 3 months before study enrollment 6. History of inflammatory gastrointestinal diseases 7. Known hypersensitivity to any component of HMPL-A580 8. Pregnant (positive pregnancy test) or lactating;
About the study
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.
What is being tested
- HMPL-A580 (drug)
- HMPL-A580 (drug)
Sponsor: Hutchmed · Participants: 186 · Started: Mar 4, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07396584
Locations in the U.S.
| California | University of California Irvine Medical Center, Orange (Not yet recruiting) |
| Florida | BRCR Global, Plantation Florida Clinical Trials Group LLC (Plantation), Plantation Florida Clinical Trials Group LLC (Tamarac), Tamarac |
| Georgia | Emory Winship Cancer Institute, Atlanta |
| Washington | University of Washington/Fred Hutchinson Cancer Center, Seattle (Not yet recruiting) |
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.