HMPL-A830 in solid tumors for adults with unresectable or metastatic cancer

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 is a two-part, multicenter phase I/IIa study of HMPL-A830 in adults with confirmed solid tumors that cannot be removed and have progressed after standard treatment. Part A focuses on safety, tolerability, and identifying the maximum tolerated or recommended dose. Part B expands to evaluate safety and preliminary efficacy at the optimized dose in selected tumor types. The study will enroll about 57 participants in dose escalation and about 90 in dose optimization, with ongoing safety monitoring and early signals of efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Understood this study and are able to voluntarily sign the informed consent form (ICF);
2. Male or Female, Age ≥ 18 years;
3. Histological confirmed, unresectable, advanced or metastatic solid tumor
4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

Exclusion Criteria:

1. 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
2. Major surgery within 28 days prior to the first dose of study drug
3. Active infection requiring systemic treatment
4. History of inflammatory gastrointestinal diseases
5. Known hypersensitivity to any component of HMPL-A830
6. Pregnant (positive pregnancy test) or lactating;

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting
• The Sixth Affiliated Hospital,Sun Yat-sen University
  Guangzhou, China Recruiting
• Shandong Cancer Hospital
  Jinan, China Recruiting
• Jiangsu Province Hospital
  Nanjing, China Recruiting
• University of California Irvine Medical Center
  Orange, California, United States Not yet recruiting
• BRCR Global
  Coral Springs, Florida, United States Not yet 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.