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

NCT06365840 | Recruiting Phase 2 DMC

• 1 other identifier: IMC-001-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

IMC-001,IMC-001-202,TMB-H

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Evaluate additional efficacy variables of IMC-001

  through study completion, an average of 1 year

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

  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)

  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)

  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)

  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).

Study Arms (1)

IMC-001

EXPERIMENTAL

Drug: IMC-001

Interventions

IMC-001 DRUG

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

IMC-001

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneOncia Therapeutics Inc.: lead

Study Sites (4)

National Cancer Center

Goyang, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

IMC-001

Study Officials

• JEEYUN LEE

  Samsung Medical Center, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUNGYOUNG LEE

CONTACT

+82 2 6283 5096; sylee@immuneoncia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

KR (4)