HMPL-A580 for adults with advanced or metastatic 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, multicenter, open-label Phase 1/2a study uses dose-escalation followed by dose-expansion cohorts to find the maximum tolerated dose and recommended dose(s) for further testing. Adult participants must have histologically confirmed unresectable advanced or metastatic solid tumors with at least one measurable lesion per RECIST v1.1 and ECOG performance status 0–1. Safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity will be measured to establish a recommended Phase 2 or Phase 3 dose. The trial is conducted at several U.S. clinical sites and enrolls participants meeting the protocol’s eligibility criteria.

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. An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
2. 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
3. Major surgery within 28 days prior to the first dose of study drug
4. Active infection requiring systemic treatment
5. Participant has received a live within 3 months before study enrollment
6. History of inflammatory gastrointestinal diseases
7. Known hypersensitivity to any component of HMPL-A580
8. Pregnant (positive pregnancy test) or lactating;

Where it's running

• BRCR Global
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group LLC (Plantation)
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group LLC (Tamarac)
  Tamarac, Florida, United States Recruiting
• Emory Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, China Recruiting
• Shanghai East Hospital
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.