A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumors, Adult

In brief

This is a first-in-human (FIH), phase Ⅰ/Ⅱa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.

Key facts

Study ID

NCT07228247

Run by

Hutchmed

People needed

147

Starts

2025-12-16

Expected to finish

2028-12-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed unresectable advanced or metastatic disease.
• Have at least one measurable lesion per RECIST v1.1;
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
• Weight ≥ 35 kg;

You may not qualify if…

• An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.
• Use of 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;
• Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy);
• Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;
• Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
• Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s);

Where it is running

• SCRI HealthONE — Denver, Colorado, United States (enrolling)
• BRCR Global — Plantation, Florida, United States (enrolling)
• Florida Clinical Trials Group LLC (Plantation) — Plantation, Florida, United States (enrolling)
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States (enrolling)
• Peking University First Hospital — Beijing, China (enrolling)
• Hunan Cancer Hospital — Changsha, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, China (enrolling)
• Florida Clinical Trials Group LLC (Tamarac) — Tamarac, Florida, United States
• START New Jersey — East Brunswick, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The First Hospital of China Medical University — Shenyang, China
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
• Fudan University Shanghai Cancer Center — Shanghai, China

Full record on ClinicalTrials.gov

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