NCT06771219 SLV-154 Treatment of Metastatic Solid Tumors
| NCT ID | NCT06771219 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Solve Therapeutics |
| Condition | Squamous Cell Cancer of Head and Neck (SCCHN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-01 |
Trial Parameters
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Brief Summary
This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Men or women (as appropriate for cancer type) of age ≥18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following: 1. SCCHN 2. NSCLC 3. SCLC 4. Breast cancer 5. Cervical cancer 6. Endometrial cancer 7. Ovarian cancer 8. Urothelial cancer 9. Sarcoma 10. Thyroid cancer 4. Presence of metastatic disease that has progressed during or following previous treatment. 5. Presence of radiographically measurable disease. 6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication. 7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy. 8. Avail
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