RECRUITING

SW-682 in Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-30
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06251310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Part 1: must have one of the following:
  3. * Mesothelioma with or without NF2 mutations
  4. * Advanced solid tumors with NF2 mutations
  5. * Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1/2, YAP fusions; WWTR1-CAMTA1 in EHE).
  6. * Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:
  7. * Cohort 1: Participants with mesothelioma with or without NF2 mutations
  8. * Cohort 2: Participants with advanced solid tumors with NF2 mutations
  9. * Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation
  10. * Cohort 4: SW-682 with appropriate combination therapy.
  11. * In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay
  12. * Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
  13. * Measurable disease per RECIST 1.1
  14. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  15. * Adequate bone marrow, kidney, hepatic, and coagulation function
  1. * Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
  2. * Clinically significant cardiac disease or abnormal cardiac parameters
  3. * Preexistence or inheritance of a familial renal syndrome
  4. * Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval
  5. * 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
  6. * 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
  7. * Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2
  8. * Clinically significant active infection (bacterial, fungal, or viral)

Contacts and Locations

Study Contact

SpringWorks Clinical
CONTACT
877-279-4870
clinical@springworkstx.com

Study Locations (Sites)

SpringWorks Clinical Trial Site
Scottsdale, Arizona, 85258
United States
SpringWorks Clinical Trial Site
La Jolla, California, 92037
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
SpringWorks Clinical Trial Site
Los Angeles, California, 90095
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Knight Cancer Institute Clinical Trials
Portland, Oregon, 97239
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: SpringWorks Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30
Study Completion Date2030-06

Study Record Updates

Study Start Date2024-07-30
Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Mesothelioma, Malignant