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

Phase 2RecruitingNCT06365840

ImmuneOncia Therapeutics Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

IMC-001DRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

ORR

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

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).

Secondary Outcomes

Evaluate additional efficacy variables of IMC-001

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

Time frame: 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

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

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

Central Contacts

SUNGYOUNG LEE

CONTACT

+82 2 6283 5068 sylee@immuneoncia.com

Data from ClinicalTrials.gov

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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

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

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)

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)

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)

Survival Outcome : Overall Survival (OS)

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

Time frame: 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)

Time frame: 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)

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