Study on ISM6331 for Patients with Advanced Mesothelioma or Other Advanced Solid Tumors

Sponsor: InSilico Medicine Hong Kong Limited

Sponsor score: 0

ClinicalTrials ID:NCT06566079

This clinical trial is testing a new drug, ISM6331, to see if it is safe and effective for treating advanced mesothelioma and other advanced solid tumors. The study will determine the best dose for future research and assess the drug's impact on tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment called ISM6331 for patients with advanced or metastatic mesothelioma and other advanced solid tumors. The trial is in two parts: the first part will test different doses to find the safest and most effective one, while the second part will expand on the best dose to see how well it works against tumors. The main goals are to evaluate the safety, tolerability, and preliminary effectiveness of ISM6331.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with advanced or metastatic mesothelioma or other solid tumors that cannot be surgically removed and have not responded to standard treatments.
  • For Part 2, patients with solid tumors other than mesothelioma must show genetic changes in the Hippo signaling pathway.
  • Patients with mesothelioma must have previously received immune checkpoint therapy and platinum-based chemotherapy.
  • Must have at least one tumor that can be evaluated or measured by scans.
  • Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live at least 12 more weeks.
  • Have adequate organ function based on medical tests.
  • Able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have previously been treated with a TEAD inhibitor.
  • Participated in another clinical trial or received anti-tumor therapy within the last 28 days or 5 half-lives of the drug.
  • Have an active brain tumor or untreated cancer spread to the brain.
  • Have severe or uncontrolled health conditions as judged by the study doctor.
  • Unable to take oral medication or have a digestive condition that affects drug absorption.
  • Have any significant health issues that could interfere with the study or affect the drug's processing in the body.
  • Currently taking certain medications that affect drug metabolism and cannot be stopped before starting the study.

Locations

FACILITYZIPCITYSTATE
Sarah Cannon Research Institute at HealthONE80218DenverColorado
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine60637ChicagoIllinois
University Hospitals Cleveland Medical Center44106ClevelandOhio
University of Pennsylvania - Abramson Cancer Center19104PhiladelphiaPennsylvania
SCRI Oncology Partners37203NashvilleTennessee
NEXT Oncology - Austin78758AustinTexas

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