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A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR

NCT06365840•ImmuneOncia Therapeutics Inc.

Summary

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

•1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
•2. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
•3. Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
•4. Adult age(as defined by respective country)
•5. The nature of the study and voluntarily sign an ICF
•6. ECOG 0 or1
•7. Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study drug.
•8. At the time of the first dose of study drug at least 28 days since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to \< Grade 2.
•9. Adequate hematologic function, hepatic function, and renal function
•10. Female participants must meet one of the following criteria:
+5 more criteria

•1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
•2. Known presence of symptomatic CNS metastases
•3. Any active autoimmune disease or a documented history of autoimmune disease
•4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
•5. Pregnant or lactating

Locations (1)

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

January 13, 2025

Primary Completion Date

December 31, 2026

Completion Date

August 1, 2029

Last Updated

June 18, 2025

Enrollment

ESTIMATED participants

Conditions

TMB-HHistologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors

Interventions

IMC-001

DRUG

Contacts

SUNGYOUNG LEE

CONTACT