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

NCT06566079 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-17

No results posted yet for this study

Summary

This is a Phase 1, 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 malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).

Conditions

  • Malignant Mesothelioma
  • Metastatic Malignant Solid Tumor
  • Advanced Solid Tumor

Interventions

DRUG

ISM6331

Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.

Sponsors & Collaborators

  • InSilico Medicine Hong Kong Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2027-08-31
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06566079 on ClinicalTrials.gov