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
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).
Arms & interventions
- DrugISM6331
Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.
Outcome measures
Primary
Incidence of dose-limiting toxicity (DLT).
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).
Time frame: Day 1 up to Day 31
Incidence and severity of adverse events (AEs)
Adverse events are assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI CTCAE v5.0\]
Time frame: Approximately 12 months.
Incidence of clinically significant abnormalities in laboratory values, vital signs, physical examination, and electrocardiogram (ECG) measurements.
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.
Time frame: Approximately 12 months.
Recommended Phase 2 Dose (RP2D)
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.
Time frame: Approximately 40 months
Secondary
Maximum observed concentration (Cmax)
Time frame: Approximately 12 months
Area under the concentration-time curve (AUC)
Time frame: Approximately 12 months
Terminal half-life (t1/2)
Time frame: Approximately 12 months
Objective response rate (ORR).
Time frame: Approximately 12 months
Best objective response (BOR).
Time frame: Approximately 12 months
Duration of response (DoR).
Time frame: Approximately 12 months
Eligibility criteria
Study locations (6)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
SCRI Oncology Partners
Nashville, Tennessee, 37203
NEXT Oncology - Austin
Austin, Texas, 78758