NCT07396584 HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
| NCT ID | NCT07396584 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hutchmed |
| Condition | Solid Tumors, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 186 participants in total. It began in 2026-03-04 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Frequently Asked Questions
Who can join the NCT07396584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07396584 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07396584 currently recruiting?
Yes, NCT07396584 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hutchmed to inquire about joining.
Where is the NCT07396584 trial being conducted?
This trial is being conducted at Orange, United States, Plantation, United States, Plantation, United States, Tamarac, United States and 10 additional locations.
Who is sponsoring the NCT07396584 clinical trial?
NCT07396584 is sponsored by Hutchmed. The trial plans to enroll 186 participants.