OncoMatch/Clinical Trials/NCT06566079
Study of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors
Official title: A Phase 1/2, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors
Is NCT06566079 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies ISM6331 for malignant mesothelioma.
Treatment: ISM6331 — This is a Phase 1/2, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic mesothelioma or other Advanced solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection expansion part (Part 2).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Mesothelioma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint therapy — malignant mesothelioma
Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy
Must have received: platinum-based chemotherapy — malignant mesothelioma
Participants with malignant mesothelioma must have prior exposure to at least ... platinum-based chemotherapy
Cannot have received: TEAD inhibitor
Participants who have previously received a TEAD inhibitor
Lab requirements
Blood counts
adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment)
Kidney function
adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment)
Liver function
adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute at HealthONE · Denver, Colorado
- The University of Chicago Medical Center - Duchossois Center for Advanced Medicine · Chicago, Illinois
- University Hospitals Cleveland Medical Center · Cleveland, Ohio
- University of Pennsylvania - Abramson Cancer Center · Philadelphia, Pennsylvania
- SCRI Oncology Partners · Nashville, Tennessee
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06566079 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior TEAD inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages