Clinical trial NCT06365840: A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
Official title: PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: TMB-H
Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
Keywords: IMC-001,IMC-001-202,TMB-H
Lead sponsor: ImmuneOncia Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ORR
timeFrame: 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:
measure: Evaluate additional efficacy variables of IMC-001
timeFrame: through study completion, an average of 1 year
measure: Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)
timeFrame: 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).
measure: Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)
timeFrame: 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).
measure: Survival Outcome : Overall Survival (OS)
timeFrame: through study completion, an average of 1 year
measure: Evaluate the pharmacokinetic (PK) profile of IMC-001
timeFrame: through study completion, an average of 1 year
measure: Characterize the immunogenicity of IMC-001
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Republic of Korea
name: JEEYUN LEE
role: PRINCIPAL_INVESTIGATOR
References: