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

PHASE 2 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.

Study Overview

• Status: Recruiting
• Conditions: TMB-H; Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
• Intervention / Treatment: Drug: IMC-001

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: SUNGYOUNG LEE; Phone Number: +82 2 6283 5096; Email: sylee@immuneoncia.com

Study Locations

• South Korea
  • Goyang, South Korea
    • Recruiting
    • National Cancer Center
    • Principal Investigator: Tak Yun, MD
  • Seongnam, South Korea
    • Recruiting
    • Seoul National University Bundang Hospital
    • Principal Investigator: Keun-Wook Lee, MD
  • Seoul, South Korea
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Jeeyun Lee, MD
  • Seoul, South Korea
    • Recruiting
    • Severance Hospital
    • Principal Investigator: MinKyu Jung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

    • 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.
11. 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.
12. Predicted life expectancy of at least 16 weeks.

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 C virus
5. Pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMC-001	Drug: IMC-001; All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate additional efficacy variables of IMC-001	Terms, frequency, severity, and seriousness of adverse events (AEs) and relationship of AEs to IMC-001	through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)	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	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).
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)	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	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).
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)	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	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).
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)	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	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).
Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)	Objective Response Rate (ORR), (Unit of Measure: Percentage of participants) Variables determined by the Investigator's assessment based on RECIST Version 1.1	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).
Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)	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)	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).
Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)	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)	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).
Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)	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)	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).
Survival Outcome : Overall Survival (OS)	Overall Survival (OS), (Unit of Measure: Months)	through study completion, an average of 1 year
Evaluate the pharmacokinetic (PK) profile of IMC-001	IMC-001 PK parameter: observed serum concentration immediately before dosing (Ctrough)	through study completion, an average of 1 year
Characterize the immunogenicity of IMC-001	Incidence of anti-drug antibody and neutralizing antibody (NAb) (including serum titers of anti-IMC-001 antibodies)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: ImmuneOncia Therapeutics Inc.
• Investigators: Principal Investigator: JEEYUN LEE, Samsung Medical Center, Republic of Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IMC-001,IMC-001-202,TMB-H
• Additional Relevant MeSH Terms: Neoplasms; IMC-001
• Other Study ID Numbers: IMC-001-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No