ISM6331 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment, ISM6331 (experimental treatment), to determine its safety and effects on tumors. It targets individuals with advanced or metastatic malignant mesothelioma or other solid tumors unresponsive to standard therapies. The trial consists of two parts: the first involves testing increasing doses of ISM6331, and the second selects the optimal dose for future use. Suitable candidates have mesothelioma or other solid tumors that cannot be treated with surgery and have previously undergone immune checkpoint therapy and platinum-based chemotherapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop any anti-tumor therapy at least 28 days before starting the study treatment. The protocol does not specify about other medications, so it's best to discuss with the study team.
Is there any evidence suggesting that ISM6331 is likely to be safe for humans?
Research has shown that ISM6331 has been promising in early safety checks. In lab studies conducted before human testing, ISM6331 was generally safe and did not cause serious side effects.
Now in a Phase 1 trial, this stage primarily assesses its safety for humans. While safety information is still being collected from participants, the goal is to ensure its safety and determine the correct dose. Participants in this trial will contribute to understanding how well people tolerate ISM6331 and identify any side effects that might occur at different doses.12345Why do researchers think this study treatment might be promising?
Unlike the standard cancer treatments like chemotherapy or radiation, which often target both healthy and cancerous cells, ISM6331 is designed to specifically target cancer cells, potentially reducing side effects. Researchers are excited about ISM6331 because it employs a novel mechanism of action, which could lead to more effective and precise cancer treatment. Additionally, ISM6331 is administered once daily, making it a convenient option for patients compared to some existing therapies that require more frequent dosing.
What evidence suggests that ISM6331 might be an effective treatment for cancer?
Research has shown that ISM6331 produced promising results in early studies. It performed well against various cancer cell types and proved effective even at low doses in animal tests. Initial patient data, particularly from those with mesothelioma, showed positive responses, suggesting potential effectiveness for this cancer type. In this trial, participants will receive ISM6331 in different dosing regimens to optimize its effectiveness. ISM6331 may also enhance current treatments by targeting mesothelioma cells that resist other therapies. Although more research is needed, these early results offer hope for treating advanced cancers.12678
Are You a Good Fit for This Trial?
Adults with advanced or metastatic malignant mesothelioma or other solid tumors who have tried at least two treatments, including immune therapy. They must be in relatively good health (ECOG ≤1), expect to live more than 12 weeks, and have proper organ function. Participants need a confirmed diagnosis and measurable disease progression after standard treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive ISM6331 once daily in sequential cohorts of increasing doses to evaluate safety and determine the recommended Phase 2 dose
Dose Selection Optimization
Participants receive ISM6331 once daily at selected dose levels to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ISM6331
Find a Clinic Near You
Who Is Running the Clinical Trial?
InSilico Medicine Hong Kong Limited
Lead Sponsor