RecruitingSolid Tumors, Adult
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Hutchmed
You may qualify if…
- ✓ 1. Histologically confirmed unresectable advanced or metastatic disease.
- ✓ 2. Have at least one measurable lesion per RECIST v1.1;
- ✓ 3. Life expectancy ≥ 12 weeks;
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
- ✓ 5. Weight ≥ 35 kg;
You may not qualify if…
- ✕ 1. An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.
- ✕ 2. 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;
- ✕ 3. 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);
- ✕ 4. Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;
- ✕ 5. 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;
- ✕ 6. 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's recruiting
Colorado
Denver
Florida
Plantation · Tamarac
New Jersey
East Brunswick
New York
New York
Ohio
Cleveland
Washington
Tacoma
Source: ClinicalTrials.gov · NCT07228247 · last updated 2026-07-07