Skip to main content
Back to Trials
NCT07718581PHASE1, PHASE2Recruiting

HMPL-A830 in Solid Tumors

Hutchmed

Start Date

9/24/2026

Completion Date

12/15/2029

Summary

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.

Detailed Description

Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors. Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors

Eligibility Criteria

Age Range: 18 years to No maximum

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;

Interventions

DRUG

HMPL-A830

DRUG

HMPL-A830

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Solid Tumor, Adult

Locations

University of California Irvine Medical Center

Orange, California 92868

United States

BRCR Global

Coral Springs, Florida 33065

United States

Florida Clinical Trials Group

Plantation, Florida 33322

United States

START New Jersey

East Brunswick, New Jersey 08816

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

START Mountain Region

West Valley City, Utah 84119

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