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SW-682 for Advanced Solid Tumors

This study is testing a new oral medication called SW-682, sometimes in combination with other therapies, for adults with advanced solid tumors, including mesothelioma. These are cancers that have spread or cannot be removed by surgery, and have not responded to or have progressed after standard treatments like chemotherapy or immunotherapy. The main goals are to find a safe dose of SW-682 and understand any side effects over about two years. This is a "first-in-human" study, meaning it's one of the first times this drug is being tested in people. The study aims to enroll 186 participants.

Study design
This is an open-label, multi-center study with two parts: a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b). It is designed to optimize the dose of SW-682 for future development.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events, maximum tolerated dose, and recommended dose for expansion for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06251310

SW-682 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
~186 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:SW-682Combination Therapy

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (Part 1 Only)
Measured over Up to 24 months
+3 more outcomes measured

Conditions

Advanced Solid Tumor
Mesothelioma, Malignant

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NCT06251310

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HonorHealth Research Institute

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • Mary Crowley Research Center US Oncology

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Oregon Health and Science University, Knight Cancer Institute - Marquam Hill

    Portland, Oregonstudy coordinator listed

    Recruiting

  • U.T. MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • UC San Diego Moores Cancer Center

    Sacramento, Californiastudy coordinator listed

    Recruiting

  • UCLA Hematology-Oncology - Santa Monica

    Santa Monica, Californiastudy coordinator listed

    Recruiting

  • University Hospital of Cleveland

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • USC Norris Comprehensive Cancer Center and Hospital

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Responsible · STUDY_DIRECTOR · SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Who to contact

US Medical Information
[email protected]
888-275-7376
Email the study team

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Eligibility criteria

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

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)

What this trial measures

  • Incidence of Adverse Events (Part 1 Only)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)

  • Maximum Tolerated Dose (Part 1 Only)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.

  • Recommended Dose for Expansion (Part 1 Only)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.

  • Objective Response Rate (Part 2 Only)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.