SW-682 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: SpringWorks Therapeutics, Inc.

Must not be taking: QTc prolongers, CYP3A4 inhibitors

Disqualifiers: CNS metastases, Cardiac disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications that affect specific liver enzymes (CYP3A4, CYP1A2, etc.) and other drug transporters at least 14 days before starting the study treatment. It's best to discuss your current medications with the trial team to see if any need to be paused.

Eligibility Criteria

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.

Inclusion Criteria

My cancer has NF2 mutations.

My cancer has specific genetic changes related to the Hippo pathway.

My advanced cancer has specific Hippo pathway mutations.

+7 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive SW-682 in varying doses to determine the maximum tolerated dose

28-day cycles

Continuous monitoring during cycles

Dose Expansion

Participants receive SW-682 at the recommended dose for expansion to evaluate efficacy

28-day cycles

Continuous monitoring during cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Participant Groups

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.

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.