Trials / Recruiting
RecruitingNCT06771219
SLV-154 Treatment of Metastatic Solid Tumors
A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Solve Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Squamous Cell Cancer of Head and Neck (SCCHN)
- NSCLC
- SCLC
- Cervical Cancer Metastatic
- Breast Cancer Metastatic
- Endometrial Cancer
- Ovarian Cancer
- Urothelial Cancer
- Sarcoma
- Thyroid Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SLV-154 | SLV-154 |
Timeline
- Start date
- 2025-05-14
- Primary completion
- 2027-01-01
- Completion
- 2027-04-01
- First posted
- 2025-01-13
- Last updated
- 2026-01-23
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06771219. Inclusion in this directory is not an endorsement.