Ovarian Cancer Clinical Trial

SW-682 in Advanced Solid Tumors

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.

View Eligibility Criteria

Eligibility Criteria

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 ≤1
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)

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

186

Study ID:

NCT06251310

Recruitment Status:

Not yet recruiting

Sponsor:

SpringWorks Therapeutics, Inc.

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There are 8 Locations for this study

See Locations Near You

SpringWorks Clinical Trial Site
Scottsdale Arizona, 85251, United States
SpringWorks Clinical Trial Site
La Jolla California, 92037, United States
SpringWorks Clinical Trial Site
Los Angeles California, 90033, United States
SpringWorks Clinical Trial Site
Los Angeles California, 90095, United States
SpringWorks Clinical Trial Site
Cleveland Ohio, 44106, United States
SpringWorks Clinical Trial Site
Portland Oregon, 97239, United States
SpringWorks Clinical Trial Site
Dallas Texas, 75230, United States
SpringWorks Clinical Trial Site
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

186

Study ID:

NCT06251310

Recruitment Status:

Not yet recruiting

Sponsor:


SpringWorks Therapeutics, Inc.

How clear is this clinincal trial information?

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