Solid Tumors, Adult
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGHMPL-A580
Part A(Phase I) Dose Escalation Enrolled participants will receive HMPL-A580 treatment in a dose escalation setting initially at 6 predefined dose levels.
Sponsors
Hutchmed
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE) | Approximately 12 months | To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors |
| Overview of Treatment-emergent Adverse Events (TEAEs) | Approximately 12 months | To characterize the safety of HMPL-A580 at RDE(s) |
| Objective Response Rate (ORR) | At least 8 weeks post dose of first participant up to approximately 24 months | To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) |
| Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580 | Approximately 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate (DCR) | Approximately 2 years | To assess the preliminary efficacy of HMPL-A580 in solid tumors |
| progression-free survival (PFS) | Approximately 2 years | To assess the preliminary antitumor activity of HMPL-A580 in selected solid tumors |
Countries
China, United States
Outcome results
None listed