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New treatment option for Advanced Solid Tumor
Official title SW-682 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06251310
What this study is testing
What is SW-682?
SW-682 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior...
- 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).
You likely can't join if
- 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...
- Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and/or CYP2B6 within 14 days or 5 half-lives before the...
See the full eligibility 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Santa Monica, California, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; Santa Monica, California, United States; Cleveland, Ohio, United States; Portland, Oregon, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.