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

Phase 1

Recruiting

• Conditions: Advanced Cancer
• Interventions: Biological: IMC-002

• Registration Number: NCT05276310
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-05-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Signed ICF
2. Histologically or cytologically proven metastatic or locally advanced solid tumors
3. Subject must have at least 1 measurable lesion by RECIST 1.1.
4. Availability of tumor archival material or fresh biopsies
5. Adequate hematologic function, hepatic function, and renal function
6. Agree to use effective contraception
7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

1. Treatment with nonpermitted drugs
2. Prior treatment with a CD47 or SIRPα targeting agent
3. Concurrent anticancer treatments
4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period
5. Previous malignant disease other than the target malignancy for this study
6. Active infection requiring systemic therapy before Day 1
7. Any active autoimmune disease, or history of autoimmune disease
8. Any psychiatric or cognitive condition
9. Known severe hypersensitivity reaction
10. Pregnant or lactating
11. Currently enrolled in another clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-002	IMC-002	1. Dose escalation will follow the traditional 3+3 design. 2. Dose expasion part

Primary Outcome Measures

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

Trial Locations

Locations (2)

Asan Medical Center, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of