RecruitingPhase 1NCT06251310

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


Sponsor

SpringWorks Therapeutics, Inc.

Enrollment

186 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new drug called SW-682 in people with advanced solid tumors that have specific changes in a pathway called the Hippo signaling pathway, which controls how cells grow. Tumors targeted include mesothelioma (a rare cancer of the lining of the lungs or abdomen) and other solid tumors with NF2, FAT1, LATS1/2, or YAP gene mutations. **You may be eligible if...** - You have an advanced or metastatic solid cancer that has not responded to or is not suitable for standard treatments - You have mesothelioma (with or without NF2 mutations), OR you have a solid tumor with NF2 or other Hippo pathway mutations/fusions - You are able to tolerate further treatment **You may NOT be eligible if...** - Your cancer does not have one of the specific Hippo pathway alterations - You have not yet tried available standard treatments - You have significant organ impairment or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSW-682

SW-682 tablet administered orally

DRUGCombination Therapy

Appropriate combination therapy


Locations(8)

SpringWorks Clinical Trial Site

Scottsdale, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

SpringWorks Clinical Trial Site

Los Angeles, California, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Knight Cancer Institute Clinical Trials

Portland, Oregon, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06251310


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