Tests SW-682 pill in adults with advanced solid tumors
Tests a new pill, SW-682, in adults with advanced solid tumors, including mesothelioma.
Plain-language title generated from the registry record
Registry title: SW-682 in Advanced Solid Tumors
Key facts
- Where
- Cleveland, Dallas, Houston, Los Angeles, Portland, Sacramento, Santa Monica, and Scottsdale, United StatesSee the 8 sites
- Phase
- Phase 1
Where in United States
- University Hospital of ClevelandCleveland, United StatesTaking people
- Mary Crowley Research Center US OncologyDallas, United StatesTaking people
- U.T. MD Anderson Cancer CenterHouston, United StatesTaking people
- USC Norris Comprehensive Cancer Center and HospitalLos Angeles, United StatesTaking people
- Oregon Health and Science University, Knight Cancer Institute - Marquam HillPortland, United StatesTaking people
- UC San Diego Moores Cancer CenterSacramento, United StatesTaking people
- UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesTaking people
- HonorHealth Research InstituteScottsdale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
- Trial code
- NCT06251310
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for which there is no treatment available or prior SOC therapy was not tolerated and for which there is no further SOC treatment available; Part 1: must have one of the following:; Mesothelioma with or without NF2 mutations; Advanced solid tumors with NF2 mutations; Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1/2, YAP fusions; WWTR1-CAMTA1 in EHE); Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:; Cohort 1: Participants with mesothelioma with or without NF2 mutations; Cohort 2: Participants with advanced solid tumors with NF2 mutations; Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation; Cohort 4: SW-682 with appropriate combination therapy; In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay; Must have archival tumor tissue or agree to a fresh tumor biopsy at screening; Measurable disease per RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of ≤1; Adequate bone marrow, kidney, hepatic, and coagulation function.
Exclusion: Concomitant medicines that are known strong/moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or CYP1A2 within 14 days or 5 half-lives before the first dose of study treatment; Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and/or CYP2B6 within 14 days or 5 half-lives before the first dose of study treatment; Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2; Clinically significant cardiac disease or abnormal cardiac parameters; Preexistence or inheritance of a familial renal syndrome; Clinically significant active infection (bacterial, fungal, or viral); Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval; Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.