New pill targets Hard-to-Treat cancers with hippo pathway mutations
NCT ID NCT06251310
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 6 times
Summary
This study tests a new drug called SW-682, taken as a tablet, for people with advanced solid tumors that have not responded to standard treatments. The trial focuses on tumors with changes in the Hippo pathway, including mesothelioma. In the first part, doctors will find the safest dose; in the second part, they will check if the drug can shrink tumors. About 186 adults will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SW-682 (an oral tablet)
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early (phase 1) trial with only 186 participants, so the drug may not work or could have serious side effects. It is not yet known if SW-682 will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 186 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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HonorHealth Research Institute
RECRUITINGScottsdale, Arizona, 85258, United States
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Mary Crowley Research Center US Oncology
RECRUITINGDallas, Texas, 75230, United States
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Oregon Health and Science University, Knight Cancer Institute - Marquam Hill
RECRUITINGPortland, Oregon, 97239, United States
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U.T. MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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UC San Diego Moores Cancer Center
RECRUITINGSacramento, California, 92093, United States
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UCLA Hematology-Oncology - Santa Monica
RECRUITINGSanta Monica, California, 90404, United States
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USC Norris Comprehensive Cancer Center and Hospital
RECRUITINGLos Angeles, California, 90033, United States
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University Hospital of Cleveland
RECRUITINGCleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Oral drug VT3989 takes on chemo in mesothelioma survival test
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?