Phase
Condition
Neoplasms
Treatment
IMC-001
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel orOncomineTM Comprehensive Assay Plus
Histologically or cytologically proven metastatic or locally advanced solidtumors.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 besubmitted 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 firstdose of study drug. Prior focal radiotherapy must be completed at least 2 weeksbefore the first dose of study drug.
At the time of the first dose of study drug at least 28 days since the lastchemotherapy, immunotherapy, biological or investigational therapy, and haverecovered 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 orbilateral oophorectomy); or
females of childbearing potential must agree to use a reliable form ofcontraceptive during the study treatment period and for at least 90 daysfollowing the last dose of study drug.
Male participants must agree to use barrier contraception (i.e., condoms) for theduration 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
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 Cvirus
Pregnant or lactating
Study Design
Connect with a study center
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang,
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam,
South KoreaActive - Recruiting
Samsung Medical Center
Seoul,
South KoreaActive - Recruiting
Severance Hospital
Seoul,
South KoreaActive - Recruiting

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