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Clinical Trials in China / NCT07396584
Recruiting Phase 1/2

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

NCT07396584 · tracked via the Priya Life Science China tracker
Sponsor
Hutchmed
Phase
Phase 1/2
Started
2026-03-04
Last updated
2026-09-18

Condition(s) studied

Solid Tumors, Adult

Investigational drug(s) / intervention(s)

HMPL-A580HMPL-A580

HMPL-A580: Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.

HMPL-A580: Part B(Phase IIa) Dose Expansion/Dose Optimization Evaluate the safety and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;

Primary outcome measure(s)

  • Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) — Approximately 12 months
    To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
  • Overview of Treatment-emergent Adverse Events (TEAEs) — Approximately 12 months
    To characterize the safety of HMPL-A580 at RDE(s)
  • Objective Response Rate (ORR) — At least 8 weeks post dose of first participant up to approximately 24 months
    To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)
  • Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580 — Approximately 12 months
    To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.

Trial sites (14)

FacilityCityRegionStatus
University of California Irvine Medical Center Orange California Not Yet Recruiting
BRCR Global Plantation Florida Recruiting
Florida Clinical Trials Group LLC (Plantation) Plantation Florida Recruiting
Florida Clinical Trials Group LLC (Tamarac) Tamarac Florida Recruiting
Emory Winship Cancer Institute Atlanta Georgia Recruiting
University of Washington/Fred Hutchinson Cancer Center Seattle Washington Not Yet Recruiting
Jilin Provincial Cancer Hospital Changchun China Not Yet Recruiting
Hunan Cancer Hospital Changsha China Not Yet Recruiting
Shandong Cancer Hospital Jinan China Not Yet Recruiting
Guangxi Medical University Cancer Hospital Nanning China Recruiting
Shanghai East Hospital Shanghai China Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China Recruiting
The First Affiliated Hospital of Xiamen University Xiamen China Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting

More Hutchmed trials in China

HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma Recruiting
HMPL-A830 in Solid Tumors Recruiting
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Active, not recruiting
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia Recruiting
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors Recruiting

Other trials for the same condition

PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors Recruiting
Granzyme B-targeted PET Imaging Monitoring Tumor Responses to Immunotherapy Starting soon
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors Recruiting
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) Recruiting
Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07396584 on ClinicalTrials.gov ↗ ← All trials in China