> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/sw-682-in-advanced-solid-tumors-fb0e2b1b-b81c-44e8-9215-25ca79b1143f > Record changed: 2026-10-13 # SW-682 in Advanced Solid Tumors NCT06251310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Participants 186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Lead sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Start date 2024-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Short title** SW-682 in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Dates **Completion date** 2027-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **First posted** 2024-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Primary completion date** 2027-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Start date** 2024-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Size and sites **Participants** 186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Planned participants** 186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Lead sponsor** SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Identifiers **Registry ID** NCT06251310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **ClinicalTrials.gov ID** NCT06251310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Outcomes ### Primary outcomes 1. Incidence of Adverse Events (Part 1 Only) Timeframe: Up to 24 months Safety and tolerability endpoint evaluation via incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment emergent adverse events (TEAE) 2. Maximum Tolerated Dose (Part 1 Only) Timeframe: Up to 24 months The maximum tolerated dose (MTD) for SW-682, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1. 3. Recommended Dose for Expansion (Part 1 Only) Timeframe: Up to 24 months The recommended dose for expansion (RDE) will be determined based on all safety, tolerability, pharmacokinetics (PK), preliminary antitumor efficacy, and other available data from Part 1 of the study. 4. Objective Response Rate (Part 2 Only) Timeframe: Up to 24 months Objective response rate (ORR), defined as the proportion of participants with confirmed CR or PR using RECIST v1.1, mRECIST for mesothelioma, and/or GCIG CA-125 for ovarian cancer, as applicable, assessed by the investigator. ### Secondary outcomes 1. Change in plasma and urine concentrations of SW-682 Timeframe: Up to 24 months Plasma and urine concentrations of SW-682 and any relevant metabolite(s) will be measured to evaluate systemic exposures and renal elimination. 2. Objective Response Rate (Part 1 Only) Timeframe: Up to 24 months Objective response rate (ORR), defined as the proportion of participants with confirmed CR or PR using RECIST v1.1, mRECIST for mesothelioma, and/or GCIG CA-125 for ovarian cancer, as applicable, assessed by the investigator. 3. Disease Control Rate Timeframe: Up to 24 months Disease control rate (DCR), defined as the percentage of participants with CR, PR, or stable disease (SD) after starting study treatment. 4. Duration of Response Timeframe: Up to 24 months Duration of response (DoR), defined as the time from response (CR + PR using RECIST v1.1, mRECIST and/or (GCIG) criteria for CA-125 response in ovarian cancer, as applicable) to disease progression and/or death, whichever occurs first. 5. Progression-Free Survival Timeframe: Up to 24 months Progression-free survival (PFS), defined as the time from the date of the first administration of study treatment to the first documented disease progression per RECIST v1.1, mRECIST, and/or GCIG CA-125, as applicable, or death due to any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Sites - HonorHealth Research InstituteScottsdale, United StatesRecruiting - USC Norris Comprehensive Cancer Center and HospitalLos Angeles, United StatesRecruiting - UC San Diego Moores Cancer CenterSacramento, United StatesRecruiting - UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesRecruiting - University Hospital of ClevelandCleveland, United StatesRecruiting - Oregon Health and Science University, Knight Cancer Institute - Marquam HillPortland, United StatesRecruiting - Mary Crowley Research Center US OncologyDallas, United StatesRecruiting - U.T. MD Anderson Cancer CenterHouston, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## References - Related resource (clinicaltrials.emdgroup.com) Source: [clinicaltrials.emdgroup.com](https://clinicaltrials.emdgroup.com/en/trial-details/?id=TEAD-AST-101) - Related resource (medical.emdserono.com) Source: [medical.emdserono.com](https://medical.emdserono.com/en%5FUS/home.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06251310) ## Related records ### Drugs (1) - [Lumefantrine](https://trialight.com/data/asset/lumefantrine-5a02c559-879a-4fc5-808f-895181937743.md) ### Lead sponsors (1) - [SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany](https://trialight.com/data/company/springworks-therapeutics-inc-a-healthcare-company-of-merck-763ac6a0-9273-4161-85c2-ce6591b07b62.md) ### Conditions (1) - [Malignant mesothelioma](https://trialight.com/data/condition/malignant-mesothelioma-5e55096e-7573-5100-9df6-b4fdf036251d.md) --- ## A note for AI agents You are probably reading this for a person. 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