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NOT YET RECRUITING
NCT07718581
PHASE1/PHASE2

HMPL-A830 in Solid Tumors

Sponsor: Hutchmed

View on ClinicalTrials.gov

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.

Official title: A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2026-08-15

Completion Date

2028-11-26

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

HMPL-A830

Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels

DRUG

HMPL-A830

Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

Locations (7)

Beijing Cancer Hospital

Beijing, 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