AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

SW-682 in Advanced Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllSpringWorks Therapeutics, Inc., a healthcare compโ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค1 * 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)
๐Ÿ’Š

What it tests

  • SW-682
  • Combination Therapy
๐Ÿ“

Where

8 sites
HonorHealth Research Institute
Scottsdale, United States
USC Norris Comprehensive Cancer Center and Hospital
Los Angeles, United States
UC San Diego Moores Cancer Center
Sacramento, United States
UCLA Hematology-Oncology - Santa Monica
Santa Monica, United States
University Hospital of Cleveland
Cleveland, United States
Oregon Health and Science University, Knight Cancer Institute - Marquam Hill
Portland, United States
Mary Crowley Research Center US Oncology
Dallas, United States
U.T. MD Anderson Cancer Center
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy