Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

Launched by INSILICO MEDICINE HONG KONG LIMITED · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ISM6331 for patients with advanced or metastatic malignant mesothelioma or other solid tumors that have not responded to standard therapies. The goal is to find out how safe this treatment is, how well it works, and to determine the best dose for future studies. The research involves two parts: the first part will look at different doses to see what is tolerable, and the second part will focus on selecting the optimal dose based on the results.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of advanced mesothelioma or another solid tumor that has not improved with previous treatments. You should have tried at least two different treatment regimens for mesothelioma. Participants must be in good overall health, be able to provide consent, and have a life expectancy of at least 12 weeks. If you join the study, you will receive the treatment and be monitored for any side effects and how well the tumor responds. This trial is currently recruiting participants, so if you think you might be eligible, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• 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 disease progression after standard therapy, intolerable to standard therapy, or for whom no 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. For participants with malignant mesothelioma, prior treatment of ≥2 regimens are required, including but not limit to immune checkpoint therapy.
• • 4. Presence of at least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for participants with non-pleural mesothelioma or other solid tumors and modified RECIST (mRECIST) v1.1 for participants with malignant pleural mesothelioma.
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
• • 6. Life expectancy of ≥12 weeks as judged by the investigator.
• • 7. Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).
• • 8. Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.
• Exclusion Criteria:
• • 1. Participants who have previously received a TEAD inhibitor.
• • 2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
• • 3. Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
• • 4. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
• • 5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
• • 6. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition
• • 7. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality or any other conditions that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study result.
• • Other protocol inclusion and exclusion criteria may apply.