Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 2, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06251310). This is a study registration, not published results. Lead sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 186 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Mesothelioma, Malignant. Interventions: DRUG: SW-682; DRUG: Combination Therapy. Primary outcome measures: Incidence of Adverse Events (Part 1 Only) , Up to 24 months; Maximum Tolerated Dose (Part 1 Only) , Up to 24 months; Recommended Dose for Expansion (Part 1 Only) , Up to 24 months; Objective Response Rate (Part 2 Only) , Up to 24 months. Brief 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.