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RECRUITING
NCT06251310
PHASE1

SW-682 in Advanced Solid Tumors

Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-07-31

Completion Date

2027-01-18

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DRUG

SW-682

SW-682 tablet administered orally

DRUG

Combination Therapy

Appropriate combination therapy

Locations (8)

HonorHealth Research Institute

Scottsdale, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

UCLA Hematology-Oncology - Santa Monica

Los Angeles, California, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Oregon Health and Science University, Knight Cancer Institute - Marquam Hill

Portland, Oregon, United States

Mary Crowley Research Center US Oncology

Dallas, Texas, United States

U.T. MD Anderson Cancer Center

Houston, Texas, United States