NCT07108114

SLV-324 Treatment of Metastatic Solid Tumors

A Phase 1 Dose-Escalation Study of SLV-324 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-324 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-324. SLV-324 will be administered intravenously (IV) in repeated cycles. Treatment will continue until progressive disease or discontinuation.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	SLV-324 intravenous (IV infusion)	SLV-324 will be administered as an IV infusion

Timeline

• Start date: 2025-08-25
• Primary completion: 2027-05-01
• Completion: 2027-08-01
• First posted: 2025-08-06
• Last updated: 2026-02-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study