SW-682 in Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
SW-682: SW-682 tablet administered orally
Combination Therapy: Appropriate combination therapy
Study 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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | Recruiting |
| USC Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | Recruiting |
| UC San Diego Moores Cancer Center | Sacramento | California | Recruiting |
| UCLA Hematology-Oncology - Santa Monica | Santa Monica | California | Recruiting |
| University Hospital of Cleveland | Cleveland | Ohio | Recruiting |
| Oregon Health and Science University, Knight Cancer Institute - Marquam Hill | Portland | Oregon | Recruiting |
| Mary Crowley Research Center US Oncology | Dallas | Texas | Recruiting |
| U.T. MD Anderson Cancer Center | Houston | Texas | Recruiting |
More SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06251310 on ClinicalTrials.gov ↗ ← All trials in the USA