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

Официальное название

PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR

Обзор

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.

Вмешательства

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

Первичные конечные точки

• ORR [Срок оценки: 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).]

Вторичные конечные точки (12)

• Evaluate additional efficacy variables of IMC-001 [Срок оценки: through study completion, an average of 1 year]
• Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: through study completion, an average of 1 year]
• Evaluate the pharmacokinetic (PK) profile of IMC-001 [Срок оценки: through study completion, an average of 1 year]
• Characterize the immunogenicity of IMC-001 [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 4 центра

• National Cancer Center — Goyang
• Seoul National University Bundang Hospital — Seongnam
• Samsung Medical Center — Seoul
• Severance Hospital — Seoul

Идентификаторы

NCT: NCT06365840 · IMC-001-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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