Clinical trial · Interventional
HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors
NCT07396584CI-TRIAL-00106619recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-A580 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A(Phase I) Dose Escalation
- interventionNames
- Drug: HMPL-A580
- type
- EXPERIMENTAL
- label
- Part B(Phase IIa) Dose Expansion/Dose Optimization
- interventionNames
- Drug: HMPL-A580
Primary outcomes (4)
- measure
- Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
- timeFrame
- Approximately 12 months
- description
- To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.