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

This is a Phase 1/2, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic mesothelioma or other Advanced solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection expansion part (Part 2).

Trial Details

NCT ID
NCT06566079
Phase
PHASE1 / PHASE2
Sponsor
InSilico Medicine Hong Kong Limited
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • ISM6331
Locations (sample)
  • Denver, Colorado, United States|39.73915,-104.9847
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Male or female participants with age ≥18 years at the time of signing the informed consent.
  • Histologically confirmed unresectable advanced or metastatic mesothelioma or other advanced solid tumors, who have failed standard therapy or for w…
  • Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.
  • 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 Tu…

For full eligibility, visit ClinicalTrials.gov.

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