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NCT Number: NCT06365840

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

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

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Key information

Conditions

TMB-H Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center, Goyang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
  • Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
  • Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
  • Adult age(as defined by respective country)
  • The nature of the study and voluntarily sign an ICF
  • ECOG 0 or1
  • 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.
  • 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.
  • Adequate hematologic function, hepatic function, and renal function
  • 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 or bilateral oophorectomy); or
  • females of childbearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study drug.
  • Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study drug.
  • Predicted life expectancy of at least 16 weeks.

Exclusion criteria

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

Treatment and study plan

IMC-001

Drug

All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes.

Primary outcomes

  1. ORR

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.

Secondary outcomes

  1. Evaluate additional efficacy variables of IMC-001

    Time frame: through study completion, an average of 1 year

    Terms, frequency, severity, and seriousness of adverse events (AEs) and relationship of AEs to IMC-001

  2. Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Progression-Free Survival (PFS), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1

  3. Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Duration of Response (DOR), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1

  4. Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Time to Progression (TTP), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1

  5. Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Disease Control Rate (DCR), (Unit of Measure: Percentage of participants) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1

  6. Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Objective Response Rate (ORR), (Unit of Measure: Percentage of participants) Variables determined by the Investigator's assessment based on RECIST Version 1.1

  7. Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Immune progression-free survival (iPFS), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)

  8. Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Immune duration of response (iDOR), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)

  9. Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)

    Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).

    Immune objective response rate (iORR), (Unit of Measure: Percentage of participants) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)

  10. Survival Outcome : Overall Survival (OS)

    Time frame: through study completion, an average of 1 year

    Overall Survival (OS), (Unit of Measure: Months)

  11. Evaluate the pharmacokinetic (PK) profile of IMC-001

    Time frame: through study completion, an average of 1 year

    IMC-001 PK parameter: observed serum concentration immediately before dosing (Ctrough)

  12. Characterize the immunogenicity of IMC-001

    Time frame: through study completion, an average of 1 year

    Incidence of anti-drug antibody and neutralizing antibody (NAb) (including serum titers of anti-IMC-001 antibodies)

Study contacts

Contact information is provided by the study sponsor or research team.

SUNGYOUNG LEE

CONTACT

[email protected]

+82 2 6283 5096

Sponsors and collaborators

Lead sponsor

ImmuneOncia Therapeutics Inc.

Industry

Registry information

Official study title

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

Acronym: TMB-H

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Apr 15, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.