HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Understood this study and are able to voluntarily sign the informed consent form (ICF);
Male or Female, Age ≥ 18 years;
Histological confirmed, unresectable, advanced or metastatic solid tumor
Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
Disqualifiers
An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
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
Major surgery within 28 days prior to the first dose of study drug
Active infection requiring systemic treatment
Trial design
Treatments tested in this trial
- HMPL-A580
- HMPL-A580
Treatment groups
186 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov