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SW-682 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by SpringWorks Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial is testing a new drug called SW-682 in adult patients with advanced solid tumors that have not responded to standard treatments. The study involves testing different doses of SW-682 to find the best

Who is the study for?
This trial is for adults with advanced solid tumors that have not improved or worsened after cancer treatments like chemo, immunotherapy, radiation, or targeted therapy. It's also open to those who can't tolerate standard care or have no other options left. Participants must have specific genetic changes in their tumors and be willing to take a new oral medication.
What is being tested?
The study tests SW-682 alone or combined with other therapies in patients with advanced solid tumors. The trial has two parts: first, finding the right dose (Phase 1a), then testing this dose more broadly (Phase 1b). Patients will take SW-682 by mouth over repeated 28-day cycles.
What are the potential side effects?
As this is a first-in-human study of SW-682, side effects are currently unknown but may include typical reactions seen with anticancer medications such as nausea, fatigue, allergic reactions, and potential organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has NF2 mutations.
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My cancer has specific genetic changes related to the Hippo pathway.
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My cancer has a known genetic mutation.
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My cancer is advanced, hasn't responded to treatments, or I can't tolerate standard treatments.
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My advanced cancer has NF2 mutations.
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I have mesothelioma, regardless of NF2 mutation status.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (Part 1 Only)
Maximum Tolerated Dose (Part 1 Only)
Objective Response Rate (Part 2 Only)
+1 more
Secondary outcome measures
Change in plasma and urine concentrations of SW-682
Disease Control Rate
Duration of Response
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 1 Dose Escalation Cohorts Ranging in DoseExperimental Treatment1 Intervention
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.
Group II: Part 2 Dose Expansion Cohort 4Experimental Treatment2 Interventions
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.
Group III: Part 2 Dose Expansion Cohort 3Experimental Treatment1 Intervention
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.
Group IV: Part 2 Dose Expansion Cohort 2Experimental Treatment1 Intervention
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.
Group V: Part 2 Dose Expansion Cohort 1Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination Therapy
2011
Completed Phase 1
~690

Find a Location

Who is running the clinical trial?

SpringWorks Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
780 Total Patients Enrolled
~124 spots leftby Jan 2030
Unbiased ResultsWe believe in providing patients with all the options.
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