A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
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Study Summary
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
1. Evaluate the safety and tolerability of HMPL-A830 in solid tumors and determine the maximum tolerated dose (MTD) and/or the recommended dose (RDO) for the optimization phase; 2. Evaluate the safety and preliminary efficacy of HMPL-A830 at the RDO level in specific solid tumors and determine the recommended dose for phase 2 or phase 3 trials (RP2D/RP3D).
The subsequent dose expansion/optimization phase will further evaluate the safety, tolerability, and preliminary antitumor activity of HMPL-A830 in selected solid tumors.
- 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
- Having fully understood this study and being able to voluntarily sign an informed consent form
- Male or female, Age 18 or older
- Unresectable, advanced, or metastatic solid tumors that are histologically or cytologically confirmed and have progressed during or after receiving current standard treatment.
- According to RECIST 1.1, there must be at least one measurable lesion; if PD meets the criteria for response evaluation, then lesions that have previously received local treatment (such as radiotherapy) are considered measurable lesions.
- Expected survival ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-1.
- 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;
- Use potent cytochrome P450 3A4 enzyme (CYP3A4) inhibitors and P-glycoprotein (P-gp) inhibitors within 2 weeks or 5 drug half-lives (whichever is longer) before the first administration of the study drug.
- Participants who underwent major surgery within 28 days prior to the first administration of the study drug, or who had not adequately recovered from complications prior to the first administration of the study drug, were also not included in the study drug administration.
- Active infection requiring systemic treatment.
- History of inflammatory gastrointestinal diseases (such as Crohn's disease or ulcerative colitis).
- A history of severe or immediate severe allergic reactions to any monoclonal antibody.
- Known allergy to any component of the investigational drug.
- Pregnant (positive pregnancy test) or breastfeeding women.
Clinical Study Information for Healthcare Providers
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