What this study is
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.
What's being tested
- HMPL-A830
Intervention · DRUG
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
- HMPL-A830
Intervention · DRUG
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
Study details
- Official title
- A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
- Sponsor
- Hutchmed
- Conditions
- Solid Tumor, Adult
- Enrolling
- 147 people
- Starts
- 2026-09-24
- Est. completion
- 2029-12-15
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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;
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openUniversity of California Irvine Medical Center
Orange, California, United States
- Zhaohui Arter · Contact714-456-7890zarter@hs.uci.edu
Not yet recruitingBRCR Global
Coral Springs, Florida, United States
- Sumit Sawhney · Contact561-447-0614Ssawhney.md@brcrglobal.com
Not yet recruitingFlorida Clinical Trials Group
Plantation, Florida, United States
- Chintan Gandhi · Contact772-297-3057cgandhi@floridactg.com
Not yet recruitingSTART New Jersey
East Brunswick, New Jersey, United States
- Bruno Fang · Contact732-390-7725Bruno.fang@startresearch.com
Not yet recruitingSCRI Oncology Partners
Nashville, Tennessee, United States
- Melissa Johnson · Contact615-329-7640mjohnson@tnonc.com
Not yet recruitingSTART Mountain Region
West Valley City, Utah, United States
- Jose Pacheco · Contact801-907-4750jose.pacheco@startresearch.com
Not yet recruiting
8 sites outside the US
- Recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, China
- Yongchang Zhang · Contact
Not yet recruitingWest China Hospital of Sichuan University
Chengdu, China
- Li Zheng · Contact
Not yet recruitingThe Sixth Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
- Yanhong Deng · Contact1392510652513925106525@163.com
Recruiting- Recruiting
Jiangsu Province Hospital
Nanjing, China
- Xiaofeng Chen · Contact+86 13585172066Xiaofengch198019@126.com
RecruitingShanxi Provincial Cancer Hospitial
Taiyuan, China
- Hongxia Lu · Contact
Not yet recruiting
Study team
Sponsor
Hutchmed
Study ID 2026-830-GLOB1
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.