A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy

Study Overview
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Brief Summary
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This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy

Detailed Description
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The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002. Multiple-dose levels of IMC-002 will be tested in subjects with advanced cancer.

Official Title
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An Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy

Conditions
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Advanced Cancer

Intervention / Treatment
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* Biological: IMC-002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed ICF Histologically or cytologically proven metastatic or locally advanced solid tumors Subject must have at least 1 measurable lesion by RECIST 1.1. Availability of tumor archival material or fresh biopsies Adequate hematologic function, hepatic function, and renal function Agree to use effective contraception Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Treatment with nonpermitted drugs Prior treatment with a CD47 or SIRPα targeting agent Concurrent anticancer treatments Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period Previous malignant disease other than the target malignancy for this study Active infection requiring systemic therapy before Day 1 Any active autoimmune disease, or history of autoimmune disease Any psychiatric or cognitive condition Known severe hypersensitivity reaction Pregnant or lactating Currently enrolled in another clinical study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Part 1: Dose Escalation Part 2: Expansion cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMC-002<br>Dose escalation will follow the traditional 3+3 design. | Biological: IMC-002<br>* IMC-002 blocks the interaction between CD47 and SIRPα.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose-Limiting Toxicities (DLTs) |  | 21 days | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | clinically significant changes in physical examination, vital signs, ECG parameters, clinical laboratory tests, AEs | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMC-002, Phase I, CD47, SIRPα