A Phase 1 Dose-Escalation Study of SLV-324 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-324 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-324. SLV-324 will be administered intravenously (IV) in repeated 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. 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 t…
Interventions
- DrugSLV-324 intravenous (IV infusion)
SLV-324 will be administered as an IV infusion
Locations (7)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Washington UniversitySt Louis, Missouri
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- MD Anderson Cancer CenterHouston, Texas
- Mays Cancer Center; University of Texas Health San AntonioHouston, Texas