SW-682 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1a/1b open-label study evaluating the safety and efficacy of SW-682 in adults with metastatic or unresectable advanced solid tumors that have not responded to previous treatments. The study consists of a dose escalation phase to determine the optimal dosage and a dose expansion phase to further assess its effectiveness. Participants will self-administer the treatment orally in 28-day cycles, focusing on those with specific genetic alterations related to the Hippo pathway.

Why it matters

Who can join: the full rules

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)

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center and Hospital
  Los Angeles, California, United States Recruiting
• UC San Diego Moores Cancer Center
  Sacramento, California, United States Recruiting
• UCLA Hematology-Oncology - Santa Monica
  Santa Monica, California, United States Recruiting
• University Hospital of Cleveland
  Cleveland, Ohio, United States Recruiting
• Oregon Health and Science University, Knight Cancer Institute - Marquam Hill
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.