A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors
Solve Therapeutics
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.
Description
A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of \~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-154. SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 treat…
Interventions
- DrugSLV-154
SLV-154
Locations (9)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Washington UniversitySt Louis, Missouri
- Astera Cancer CareEast Brunswick, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas
- Oncology ConsultantsHouston, Texas