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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-001 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-001 | Drug | All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes. |
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| 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). |
| 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) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SUNGYOUNG LEE | Contact | +82 2 6283 5096 | sylee@immuneoncia.com |
| Name | Affiliation | Role |
|---|---|---|
| JEEYUN LEE | Samsung Medical Center, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang | South Korea |
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| ID | Term |
|---|---|
| C000722928 | IMC-001 |
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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 |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Severance Hospital | Recruiting | Seoul | South Korea |
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