Study on ISM3412 for Patients with Advanced or Metastatic Solid Tumors

Sponsor: InSilico Medicine Hong Kong Limited

Sponsor score: 0

ClinicalTrials ID:NCT06414460

This clinical trial is testing a new drug, ISM3412, to see if it is safe and well-tolerated in patients with advanced or metastatic solid tumors. The study will also determine the best dose for future research.

Patient Parameters

Program Overview

The study is divided into two parts. The first part will gradually increase the dose of ISM3412 to find a safe level, while the second part will optimize the dose. The main goals are to evaluate the safety of ISM3412 and to find the most effective dose for patients with advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have advanced or metastatic solid tumors that cannot be surgically removed and have a specific genetic deletion (MTAP deletion).
  • Have tried standard treatments without success, cannot tolerate them, or have no standard treatment options available.
  • Have tumors that can be measured or evaluated.
  • 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.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ function based on medical tests.
  • Be able to understand and sign a consent form and follow study requirements.

Exclusion Criteria

  • Have previously been treated with MAT2A or PRMT inhibitors.
  • Have participated in another clinical trial within the last 28 days.
  • Have received any anti-cancer treatment within the last 28 days.
  • Have not fully recovered from side effects of previous treatments.
  • Have had another type of cancer diagnosed or treated in the last 3 years.
  • Have a history of Gilbert's syndrome or myelodysplastic syndrome.
  • Have had an organ or stem cell transplant.
  • Have active or untreated cancer in the brain or central nervous system.
  • Have serious heart or blood vessel diseases.
  • Have an uncontrolled infection.
  • Have difficulty taking oral medications or have a gastrointestinal condition that affects drug absorption.

Locations

FACILITYZIPCITYSTATE
Sarah Cannon Research Institute at HealthONE80218DenverColorado
Smilow Cancer Hospital at Yale New Haven Breast Center06520-8028New HavenConnecticut
Community Cancer Center North46250-2042IndianapolisIndiana
SCRI Oncology Partners37203NashvilleTennessee
The University of Texas MD Anderson Cancer Center77030-4095HoustonTexas

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