HMPL-A251 for adults with advanced or metastatic HER2-expressing solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label phase I/IIa study gives HMPL-A251 as monotherapy to adults with previously treated, unresectable or metastatic HER2-expressing solid tumors. The study begins with dose-escalation to determine the maximum tolerated dose and/or recommended dose(s) for expansion, then uses expansion cohorts to characterize safety and preliminary anti-tumor activity at those doses. Key outcome measures include safety and tolerability, dose-limiting toxicities, and objective tumor response by RECIST v1.1, with enrolled patients required to have measurable disease and an ECOG performance status of 0–1. The protocol also screens for drug interactions and unresolved toxicities from prior therapies before enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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;

Exclusion Criteria:

1. An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.
2. Use of strong inhibitors or strong inducers 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 running

• SCRI HealthONE
  Denver, Colorado, United States Recruiting
• BRCR Global
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group LLC (Plantation)
  Plantation, Florida, United States Recruiting
• Cleveland Clinic Taussig Cancer Center
  Cleveland, Ohio, United States Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• Hunan Cancer Hospital
  Changsha, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.