SW-682 in Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Study ID
NCT06251310
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Mesothelioma, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SW-682 — DRUG
    SW-682 tablet administered orally
  • Combination Therapy — DRUG
    Appropriate combination therapy

Study Details

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.

Key Dates

First listed
Feb 9, 2024
Start date
Jul 31, 2024
Status verified
Jun 2026
Primary completion
Jan 18, 2027
Completion
Jan 18, 2027

Study Design

Enrollment
186 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation Cohorts Ranging in Dose
    Participants with advanced solid tumors with or without Hippo pathway mutations will receive SW-682 tablets administered orally in continuous 28-day cycles. SW-682 dosage and frequency of administration will vary by cohort.
  • Experimental: Part 2 Dose Expansion Cohort 1
    Participants with mesothelioma with or without NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.
  • Experimental: Part 2 Dose Expansion Cohort 2
    Participants with advanced solid tumors with NF2 mutations will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.
  • Experimental: Part 2 Dose Expansion Cohort 3
    Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data.
  • Experimental: Part 2 Dose Expansion Cohort 4
    Participants will receive SW-682 tablets administered orally in continuous 28-day cycles at the recommended dose for expansion, based on Part 1 data, with appropriate combination therapy, identified based on Part 1 data.

Primary Outcome Measure

Incidence of Adverse Events (Part 1 Only) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Nurse Navigation Team
[email protected]
480-323-1791
Nurse Navigation Team
[email protected]
833-354-6667
Muhammad R Khawaja, MD (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Katherine Velasco
[email protected]
858-822-5677
Sandip Patel, MD (PRINCIPAL_INVESTIGATOR)
UCLA Hematology-Oncology - Santa MonicaLos AngelesCalifornia90095
Jacqueline Banuelos Murillo
[email protected]
310-633-8400
Arun S Singh, MD (PRINCIPAL_INVESTIGATOR)
USC Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90033
Diana Hanna, MD
[email protected]
Diana Hanna, MD (PRINCIPAL_INVESTIGATOR)
University Hospital of ClevelandClevelandOhio44106
Afshin Dowlati, MD
[email protected]
216-844-3951
Amanda Pawlus
[email protected]
Afshin Dowlati, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University, Knight Cancer Institute - Marquam HillPortlandOregon97239
[email protected]
503-494-1080
Grace PArk
[email protected]
Shivaani Kummar (PRINCIPAL_INVESTIGATOR)
Mary Crowley Research Center US OncologyDallasTexas75230
Douglas Orr, MD
[email protected]
972-566-3000
Douglas Orr, MD (PRINCIPAL_INVESTIGATOR)
U.T. MD Anderson Cancer CenterHoustonTexas77030
Ileana Gutierrez
[email protected]
713-563-2158
Minh Nguyen
[email protected]
Timothy Yap, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute· Scottsdale, AZUC San Diego Moores Cancer Center· La Jolla, CAUCLA Hematology-Oncology - Santa Monica· Los Angeles, CAUSC Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity Hospital of Cleveland· Cleveland, OHOregon Health and Science University, Knight Cancer Institute - Marquam Hill· Portland, OR

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