Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
{ "Study of ISM6331 for Advanced Mesothelioma or Other Solid Tumors", "This study is testing a new oral capsule medication called ISM6331 for people with advanced or metastatic (spread to other parts of the body) malignant mesothelioma or other solid tumors. You might be able to join if your cancer has not responded to standard treatments or if there are no other effective treatments available. The main goals are to understand the safety of ISM6331, find the best dose, and see if it shows any signs of helping to fight the cancer. Researchers will be looking for any side effects and changes in your lab results, vital signs, and physical exams over about 12 months. This is an early-stage study, and about 100 people are expected to participate.", "design": "This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving ISM6331. It will involve about 100 participants and has two parts: one to find the right dose and another to optimize that dose.", "commitments": "You will take ISM6331 once daily. Researchers will monitor you for side effects and other health changes for approximately 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "Your health will be monitored for side effects and other changes for approximately 12 months after starting the study.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
At a glance
Conditions
Where it's being run
10 sites across 9 statesWho to contact
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What this trial measures
- 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.