A Phase 1 Dose-Escalation/Expansion Study of SLV-154 in Subjects With Advanced Cancers
Solve Therapeutics
Summary
This is a Phase 1 study comprising a Phase 1a dose-escalation portion and a Phase 1b expansion portion evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with advanced 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. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men or women (as appropriate for cancer type) of age ≥12 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records. 4. Presence of metastatic or recurrent locally advanced cancer. 5. Presence of radiographically measurable disease. 6. Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolvi…
Interventions
- DrugSLV-154
SLV-154
Locations (10)
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Washington UniversitySt Louis, Missouri
- Astera Cancer CareEast Brunswick, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- MD Anderson Cancer CenterHouston, Texas