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
Apply to this trial

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

Start date
Jul 30, 2024
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2030

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
SpringWorks Clinical Trial SiteScottsdaleArizona85258
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)
SpringWorks Clinical Trial SiteLos AngelesCalifornia90095
Jacqueline Banuelos Murillo
[email protected]
310-633-8400
Arun S Singh, MD (PRINCIPAL_INVESTIGATOR)
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Xiomara Menendez, RN
[email protected]
323-865-0212
Diana Hanna, MD
[email protected]
University Hospitals Cleveland Medical CenterClevelandOhio44106
Afshin Dowlati, MD
[email protected]
216-844-3951
Afshin Dowlati, MD (PRINCIPAL_INVESTIGATOR)
Knight Cancer Institute Clinical TrialsPortlandOregon97239
[email protected]
503-494-1080
Shivaani Kummar (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Douglas Orr, MD
[email protected]
972-566-3000
Douglas Orr, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Ileana Gutierrez
[email protected]
713-563-2158
Timothy Yap, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
SpringWorks Clinical Trial Site· Scottsdale, AZUC San Diego Moores Cancer Center· La Jolla, CASpringWorks Clinical Trial Site· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAUniversity Hospitals Cleveland Medical Center· Cleveland, OHKnight Cancer Institute Clinical Trials· Portland, OR

Related Studies