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

Last updated: April 16, 2026
Sponsor: ImmuneOncia Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

IMC-001

Clinical Study ID

NCT06365840
IMC-001-202
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel orOncomineTM Comprehensive Assay Plus

  2. Histologically or cytologically proven metastatic or locally advanced solidtumors.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 besubmitted 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 firstdose of study drug. Prior focal radiotherapy must be completed at least 2 weeksbefore the first dose of study drug.

  8. At the time of the first dose of study drug at least 28 days since the lastchemotherapy, immunotherapy, biological or investigational therapy, and haverecovered 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:

  • Postmenopausal (≥24 months, or ≥12 months with FSH > 40 IU/L),

  • surgically incapable of bearing children (i.e., has had a hysterectomy orbilateral oophorectomy); or

  • females of childbearing potential must agree to use a reliable form ofcontraceptive during the study treatment period and for at least 90 daysfollowing the last dose of study drug.

  1. Male participants must agree to use barrier contraception (i.e., condoms) for theduration of the study and for at least 90 days after the last dose of study drug.

  2. Predicted life expectancy of at least 16 weeks.

Exclusion

Exclusion 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 Cvirus

  5. Pregnant or lactating

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: IMC-001
Phase: 2
Study Start date:
January 13, 2025
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang,
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam,
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    South Korea

    Active - Recruiting

  • Severance Hospital

    Seoul,
    South Korea

    Active - Recruiting

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