This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas. Male or female subjects 18 years and older with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas will be included in the study if they meet all the inclusion criteria and none of the exclusion criteria. The study will consist of 2 parts: Part 1: Dose Escalation Part 2: Expansion Cohorts
Part 1: Dose Escalation Part 2: Expansion Cohort The study may be amended in the future to include expansion cohorts in selected tumor types to further evaluate extended safety of IMC-002 at recommended Phase 2 dose in that tumor type. Sample size in the Dose Expansion part will be determined when the study is amended to include the expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IMC-002 blocks the interaction between CD47 and SIRPα.
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Seoul National University Hospital
Seoul, South Korea
Occurrence of dose-limiting toxicities (DLT)
Time frame: For 28 days
Incidence and severity of adverse events (AEs)
Time frame: 2 years
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