HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.

To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.

Inclusion criteria

• 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
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

Exclusion criteria

• 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
• Participant has received a live within 3 months before study enrollment
• History of inflammatory gastrointestinal diseases
• Known hypersensitivity to any component of HMPL-A580
• Pregnant (positive pregnancy test) or lactating;