SW-682 for Solid Tumors

Recruiting at 15 trial locations

Overseen By SpringWorks Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SpringWorks Therapeutics, Inc.

Must not be taking: QTc prolongers, CYP3A4 inhibitors

Disqualifiers: CNS metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, SW-682, for individuals with advanced solid tumors, such as mesothelioma, that have not responded to standard therapies. The trial aims to determine the optimal dosage for this drug, with participants taking it in 28-day cycles. Various groups are included to assess the treatment's effectiveness with different genetic changes in tumors, including mutations in the NF2 or Hippo pathways. Ideal candidates are those whose cancer has not improved with other treatments and have specific tumor mutations identified in previous tests. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that SW-682 is likely to be safe for humans?

Research shows that SW-682 is under study to determine its safety and effectiveness in treating advanced solid tumors. Since this is the first human trial of SW-682, information about its safety remains limited. The main goal of this Phase 1 trial is to identify a safe dose and assess tolerability. Phase 1 trials typically involve small groups, allowing researchers to closely monitor side effects and understand the body's response to the drug.

Participants take SW-682 tablets orally every 28 days. The trial adjusts doses to determine a safe and effective amount. Researchers closely observe participants' responses to the treatment. Some side effects may occur, which is normal as they learn more about the drug's effects in humans.

If SW-682 is well-tolerated and shows positive results, it may advance to further studies focusing on efficacy. Until then, the information collected in this trial will be crucial for understanding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SW-682 for treating solid tumors because it targets the Hippo pathway, which is often involved in tumor growth, making it a novel approach compared to standard chemotherapy and radiation. Unlike traditional treatments, SW-682 specifically addresses genetic mutations such as NF2, potentially offering more personalized and effective therapy. Additionally, SW-682 is administered orally, which could improve patient convenience and adherence compared to treatments that require intravenous administration.

What evidence suggests that SW-682 could be an effective treatment for advanced solid tumors?

Research has shown that targeting the Hippo pathway might help treat certain solid tumors. This pathway controls cell growth and survival, and issues with it are linked to cancer. In mesothelioma, about 30% to 40% of cases involve changes in the NF2 gene, part of this pathway. SW-682, the investigational treatment in this trial, targets these changes. Participants will receive SW-682 to address these specific genetic mutations, potentially slowing tumor growth. Although human studies have provided limited information, this trial aims to evaluate the effectiveness of SW-682 in targeting these mutations. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SW-682

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1 Dose Escalation Cohorts Ranging in Dose Experimental Treatment 1 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 4 Experimental Treatment 2 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

SpringWorks Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

900+

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/459495

SW-682 in Advanced Solid Tumors - Carebox Connect 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 ...

2. uclahealth.org uclahealth.org/clinical-trials/sw-682-advanced-solid-tumors

SW-682 in Advanced Solid Tumors 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 ...

3. healthscout.app healthscout.app/trial_match/view_trial/NCT06251310/?back=/trial_match/view_trials/condition/mesothelioma/%3Fpage%3D3

Trial: SW-682 in Advanced Solid Tumors - HealthScout This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10168293/

NF2 alteration in mesothelioma - PMC - PubMed Central - NIH The NF2 tumor suppressor gene is a frequent somatically mutated gene in mesothelioma, with 30%–40% mesotheliomas showing NF2 inactivation.

5. oncologypipeline.com oncologypipeline.com/apexonco/insilico-still-feels-need-tead

Insilico still feels the need for TEAD | ApexOnco Targeting the Hippo/Yap/TEAD pathway hasn't worked well for Ikena, but this hasn't stopped other groups from getting involved.

6. mesotheliomahope.com mesotheliomahope.com/treatment/clinical-trials/

Mesothelioma Clinical Trials | Active Recruiting Trials 2025 ... SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations. Conditions. Mesothelioma, Malignant.

7. synapse.patsnap.com synapse.patsnap.com/drug/375454a460c05815e86c5f64e4da29bb

SW-682 - Drug Targets, Indications, Patents A Phase 1a/1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations.