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

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.

Interventions

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

Primary outcome measures

• ORR [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 outcome measures (12)

• Evaluate additional efficacy variables of IMC-001 [Time frame: through study completion, an average of 1 year]
• Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS) [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).]
• Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR) [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).]
• Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP) [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).]
• Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR) [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).]
• Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR) [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).]
• Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS) [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).]
• Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR) [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).]
• Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR) [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).]
• Survival Outcome : Overall Survival (OS) [Time frame: through study completion, an average of 1 year]
• Evaluate the pharmacokinetic (PK) profile of IMC-001 [Time frame: through study completion, an average of 1 year]
• Characterize the immunogenicity of IMC-001 [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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:

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 4 centers

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

Identifiers

NCT: NCT06365840 · IMC-001-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗