RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

HMPL-A830 in Solid Tumors

Sponsor: Hutchmed • ClinicalTrials.gov ID: NCT07718581

Registry updated: 2026-10-01

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Description

This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors\*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts: Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled. Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.

Interventions

HMPL-A830 (Drug)
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
HMPL-A830 (Drug)
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

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. 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 2. Major surgery within 28 days prior to the first dose of study drug 3. Active infection requiring systemic treatment 4. History of inflammatory gastrointestinal diseases 5. Known hypersensitivity to any component of HMPL-A830 6. Pregnant (positive pregnancy test) or lactating;

Conditions

Solid Tumor, Adult

Locations

University of California Irvine Medical Center — Orange, California, United States
BRCR Global — Coral Springs, Florida, United States
Florida Clinical Trials Group — Plantation, Florida, United States
START New Jersey — East Brunswick, New Jersey, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
START Mountain Region — West Valley City, Utah, United States
Beijing Cancer Hospital — Beijing, China
Jilin Cancer Hospital — Changchun, China
Hunan Cancer Hospital — Changsha, China
West China Hospital of Sichuan University — Chengdu, China
The Sixth Affiliated Hospital,Sun Yat-sen University — Guangzhou, China
Shandong Cancer Hospital — Jinan, China
Jiangsu Province Hospital — Nanjing, China
Shanxi Provincial Cancer Hospitial — Taiyuan, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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