Recruiting

SW-682 for Advanced Solid Tumors with Hippo Pathway Mutations

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What is being tested

SW-682

+ Combination Therapy

Drug
Who is being recruted

Mesothelioma, Malignant+11

+ Adenoma

+ Lung Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorSpringWorks Therapeutics, Inc.
Study ContactSpringWorks Clinical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 30, 2024

Actual date on which the first participant was enrolled.

This study is focused on testing a new drug called SW-682 in adults who have advanced solid tumors, which are types of cancer that have spread or cannot be removed by surgery. It is especially interested in patients whose cancer has certain changes in the Hippo pathway, a specific cell signaling pathway. These participants have already tried other treatments like chemotherapy or immunotherapy but have not had success, or they couldn't tolerate those treatments. The goal is to find a safe and effective dose of SW-682 for further research. This study is crucial as it can potentially offer a new treatment option for patients who have limited choices left due to the progression or resistance to existing therapies. Participants in this study will take the medication SW-682 orally, meaning they will swallow it, for a period of 28 days per cycle. The study is divided into two parts: the first part is to gradually increase the dose to see how much can be safely given, and the second part will expand the number of participants to further assess the effects at the chosen dose. Researchers will closely monitor how the body responds to the drug, focusing on safety and the drug's impact on the tumors. While potential benefits include discovering a new effective treatment, there are also risks, such as unknown side effects, since this is the first time SW-682 is being tested in humans.

Official TitleA Phase 1a/1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations
NCT06251310
Principal SponsorSpringWorks Therapeutics, Inc.
Study ContactSpringWorks Clinical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mesothelioma, MalignantAdenomaLung DiseasesLung NeoplasmsMesotheliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPleural NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms, Mesothelial

Criteria

8 exclusion criteria prevent from participating
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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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 III

Experimental
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

Experimental
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 5

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

SpringWorks Clinical Trial Site

Scottsdale, United StatesOpen SpringWorks Clinical Trial Site in Google Maps
Recruiting

UC San Diego Moores Cancer Center

La Jolla, United States
Recruiting

USC/Norris Comprehensive Cancer Center

Los Angeles, United States
Recruiting

SpringWorks Clinical Trial Site

Los Angeles, United States
Recruiting
8 Study Centers