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HMPL-A830 in Solid Tumors
Sponsor: Hutchmed
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
Conditions
Interventions
HMPL-A830
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
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