Actively Recruiting
SW-682 in Advanced Solid Tumors
Led by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany · Updated on 2026-05-08
186
Participants Needed
8
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SW-682 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically confirmed metastatic or unresectable solid tumors that have progressed during or after prior systemic anticancer therapies or have no available treatments
- Part 1: Participants with mesothelioma (with or without NF2 mutations), advanced solid tumors with NF2 mutations, or advanced solid tumors with other Hippo pathway mutations or fusions
- Part 2: Participants assigned to dose expansion cohorts based on tumor type and specific Hippo pathway mutations
- Known oncogenic mutation identified by Next Generation Sequencing or local assay
- Availability of archival tumor tissue or agreement to fresh tumor biopsy at screening
- Measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Adequate bone marrow, kidney, liver, and coagulation function
You will not qualify if you...
- Presence of symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
- Clinically significant heart disease or abnormal cardiac test results
- Preexisting familial renal syndrome
- Use of non-anti-arrhythmic medications known to prolong QTc interval
- Use of medications that are strong/moderate inhibitors or inducers of CYP3A4 or CYP1A2 within 14 days or 5 half-lives before starting study treatment
- Use of medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, or CYP2B6 within 14 days or 5 half-lives before starting study treatment
- Use of medications that are sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, or OCT2
- Clinically significant active infection (bacterial, fungal, or viral)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
SpringWorks Clinical Trial Site
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
SpringWorks Clinical Trial Site
Los Angeles, California, United States, 90095
Actively Recruiting
5
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
6
Knight Cancer Institute Clinical Trials
Portland, Oregon, United States, 97239
Actively Recruiting
7
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
8
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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