A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
InSilico Medicine Hong Kong Limited
Summary
This is a Phase 1, 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 malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have failed standard therapy or for whom no effective standard therapy exists, participants for part 1 is regardless of the presence or absence of the genetic alterations of the Hippo pathway, but for part 2 participants with solid tumors other than mesothelioma, genetic testing documentation must demonstrate Hippo signaling pathway dysregulation. 3. Participants with…
Interventions
- DrugISM6331
Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.
Locations (10)
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- The University of Chicago Medical Center - Duchossois Center for Advanced MedicineChicago, Illinois
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- University of Pennsylvania - Abramson Cancer CenterPhiladelphia, Pennsylvania
- SCRI Oncology PartnersNashville, Tennessee
- NEXT Oncology - AustinAustin, Texas