NCT06251310

SW-682 in Advanced Solid Tumors

A Phase 1a/1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: SpringWorks Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.

Conditions

• Advanced Solid Tumor
• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	SW-682	SW-682 tablet administered orally
DRUG	Combination Therapy	Appropriate combination therapy

Timeline

• Start date: 2024-07-30
• Primary completion: 2030-01-01
• Completion: 2030-06-01
• First posted: 2024-02-09
• Last updated: 2026-04-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study