SW-682 in Advanced Solid Tumors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests SW-682 in people for the first time to find a dose for future studies. It is for adults with solid cancers that have spread or cannot be removed by surgery, when past treatment has not worked or no standard treatment is left. People take SW-682 by mouth in 28-day cycles.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have solid cancer confirmed by a tissue test that has spread or cannot be removed by surgery. Past treatment must have failed, no treatment is available, or standard treatment caused side effects you could not tolerate and no standard options remain.
- For Part 1, have mesothelioma (cancer of the lining around some organs), with or without an NF2 gene change, or another advanced solid cancer with an NF2 or other Hippo pathway gene change. This pathway helps control cell growth.
- For Part 2, meet your group's cancer and gene-change rules: mesothelioma, solid cancer with an NF2 change, or solid cancer with another Hippo pathway change found during Part 1. A fourth group tests SW-682 with another suitable treatment.
- In either part, have a known cancer-driving gene change found by genetic testing.
- Have a saved tumor sample or agree to have a new tumor sample taken before treatment.
- Have cancer that can be measured on scans using the study's rules.
- Be fully active or able to walk and do light work, even if hard physical activity is limited.
- Have blood cell production, kidneys, liver, and blood clotting that work well enough.
Who can't join
- Have cancer spread to the brain or spinal cord that causes symptoms, cancer in the tissue around them, or untreated pressure on the spinal cord.
- Have a serious heart condition or abnormal heart test results.
- Have an existing or inherited family-linked kidney condition.
- Take certain medicines that can delay the heart's electrical reset between beats, other than medicines for an irregular heartbeat.
- Take certain medicines that change how the body breaks down drugs too close to the first study dose. The listed window is 14 days or 5 drug half-lives—the time needed for a drug's level to drop by half.
- Take certain medicines whose breakdown is easily affected by other drugs within that same window before the first dose.
- Take certain medicines affected by proteins that move drugs through the body.
- Have a serious active infection caused by bacteria, fungi, or viruses.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (8)
AZ
- HonorHealth Research Institute · Scottsdale, AZ 85258 · Study contact · mkhawaja@honorhealth.comMuhammad R Khawaja, MD · Principal investigatorMore trials in Scottsdale
CA
- USC Norris Comprehensive Cancer Center and Hospital · Los Angeles, CA 90033 · Study contact · diana.hanna@med.usc.eduDiana Hanna, MD · Principal investigatorMore trials in Los Angeles
- UC San Diego Moores Cancer Center · Sacramento, CA 92093 · Study contact · sandippatel@ucsd.eduSandip Patel, MD · Principal investigatorMore trials in Sacramento
- UCLA Hematology-Oncology - Santa Monica · Santa Monica, CA 90404 · Study contact · Asingh@mednet.ucla.eduArun S Singh, MD · Principal investigatorMore trials in Santa Monica
OH
- University Hospital of Cleveland · Cleveland, OH 44106 · Study contact · 216-844-3951 · afshin.dowlati@uhhospitals.orgAfshin Dowlati, MD · Principal investigatorMore trials in Cleveland
OR
- Oregon Health and Science University, Knight Cancer Institute - Marquam Hill · Portland, OR 97239 · Study contact · kummar@ohsu.eduShivaani Kummar · Principal investigatorMore trials in Portland
TX
- Mary Crowley Research Center US Oncology · Dallas, TX 75230 · Study contact · 972-566-3000 · Douglas.Orr@scri.comDouglas Orr, MD · Principal investigatorMore trials in Dallas
- U.T. MD Anderson Cancer Center · Houston, TX 77030 · Study contact · TYap@mdanderson.orgTimothy Yap, MD · Principal investigatorMore trials in Houston