HMPL-A580 for adults with advanced or metastatic solid tumors
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
This tests whether HMPL-A580 is safe and might help adults with unresectable advanced or metastatic solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hutchmed Industry-sponsored |
| Locations | 11 sites (Orange, California and 10 other locations) |
| Trial ID | NCT07396584 on ClinicalTrials.gov |
What this trial studies
This first-in-human, multicenter, open-label Phase 1/2a study uses dose-escalation followed by dose-expansion cohorts to find the maximum tolerated dose and recommended dose(s) for further testing. Adult participants must have histologically confirmed unresectable advanced or metastatic solid tumors with at least one measurable lesion per RECIST v1.1 and ECOG performance status 0–1. Safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity will be measured to establish a recommended Phase 2 or Phase 3 dose. The trial is conducted at several U.S. clinical sites and enrolls participants meeting the protocol’s eligibility criteria.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed unresectable, advanced or metastatic solid tumors, measurable disease by RECIST v1.1, ECOG 0–1, and life expectancy of at least 12 weeks are the intended candidates.
Not a fit: Patients with uncontrolled diabetes, recent major surgery, active infection, recent live vaccine, or those taking strong CYP3A4/P-gp/BCRP inhibitors may be excluded and are less likely to benefit from participation.
Why it matters
Potential benefit: If successful, HMPL-A580 could provide a new treatment option that slows tumor growth or controls disease in some patients with advanced solid tumors.
How similar studies have performed: This is a first-in-human program; while some other early-phase targeted therapies have shown promise in select solid tumors, efficacy of HMPL-A580 is currently unproven.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Orange, California and 10 other locations
- University of California Irvine Medical Center — Orange, California, United States (Not_yet_recruiting)
- BRCR Global — Plantation, Florida, United States (Not_yet_recruiting)
- Florida Clinical Trials Group LLC (Plantation) — Plantation, Florida, United States (Not_yet_recruiting)
- Florida Clinical Trials Group LLC (Tamarac) — Tamarac, Florida, United States (Not_yet_recruiting)
- University of Washington/Fred Hutchinson Cancer Center — Seattle, Washington, United States (Not_yet_recruiting)
- Hunan Cancer Hospital — Changsha, China (Not_yet_recruiting)
- Guangxi Medical University Cancer Hospital — Nanning, China (Not_yet_recruiting)
- Shanghai East Hospital — Shanghai, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xiamen University — Xiamen, China (Not_yet_recruiting)
- Henan Cancer Hospital — Zhengzhou, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.