HMPL-A830 in Solid Tumors
Starting soon · Phase 1/Phase 2
Conditions studied: Solid Tumor, Adult
In brief
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.
Key facts
- Study ID
- NCT07718581
- Run by
- Hutchmed
- People needed
- 147
- Starts
- 2026-08-15
- Expected to finish
- 2028-11-26
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
You may not qualify if…
- 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
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A830
- Pregnant (positive pregnancy test) or lactating;
Where it is running
- 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
Full record on ClinicalTrials.gov
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