Study of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
ISM6331: Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicity (DLT). — Day 1 up to Day 31
DLT is defined as any adverse event which meets DLT criteria unless it is clearly related to disease progression or intercurrent illness during the first 31 days after the initiation of treatment in the dose escalation part (Part 1). - Incidence and severity of adverse events (AEs) — Approximately 12 months.
Adverse events are assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI CTCAE v5.0\] - Incidence of clinically significant abnormalities in laboratory values, vital signs, physical examination, and electrocardiogram (ECG) measurements. — Approximately 12 months.
Regular monitoring and assessment of vital signs (pulse rate, blood pressure, respiratory rate, and temperature), physical examinations, laboratory values, ECG, and other safety examinations by investigators. - Recommended Phase 2 Dose (RP2D) — Approximately 40 months
The RP2D will be recommended by safety review committee (SRC) upon reviewing all available safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data from Part 1 and Part 2.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | Recruiting |
| The University of Chicago Medical Center - Duchossois Center for Advanced Medicine | Chicago | Illinois | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| NEXT Oncology - Austin | Austin | Texas | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China | Recruiting |
| Sun Yat-Sen University Cancer Center | Guangzhou | China | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06566079 on ClinicalTrials.gov ↗ ← All trials in the USA