SW-682 for 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
This study is testing a new oral treatment called SW-682 to see if it can help adults with advanced solid tumors that haven't improved with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 8 sites (Scottsdale, Arizona and 7 other locations) |
| Trial ID | NCT06251310 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1a/1b open-label study evaluating the safety and efficacy of SW-682 in adults with metastatic or unresectable advanced solid tumors that have not responded to previous treatments. The study consists of a dose escalation phase to determine the optimal dosage and a dose expansion phase to further assess its effectiveness. Participants will self-administer the treatment orally in 28-day cycles, focusing on those with specific genetic alterations related to the Hippo pathway.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic or unresectable solid tumors, particularly those with mesothelioma or specific Hippo pathway mutations.
Not a fit: Patients with early-stage tumors or those who have not undergone prior systemic anticancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to existing therapies.
How similar studies have performed: While this approach is novel, similar studies targeting specific genetic alterations in advanced cancers have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression * Clinically significant cardiac disease or abnormal cardiac parameters * Preexistence or inheritance of a familial renal syndrome * Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval * 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 active infection (bacterial, fungal, or viral)
Where this trial is running
Scottsdale, Arizona and 7 other locations
- SpringWorks Clinical Trial Site — Scottsdale, Arizona, United States (Recruiting)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- SpringWorks Clinical Trial Site — Los Angeles, California, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Knight Cancer Institute Clinical Trials — Portland, Oregon, United States (Recruiting)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: US Medical Information
- Email: eMediUSA@emdserono.com
- Phone: 888-275-7376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.