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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276310
• Other study ID #: IMC-002-K102
• Status: Recruiting
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: ImmuneOncia Therapeutics Inc.
• Contact: SUNG YOUNG LEE
• Phone: +82 2 6283 5068
• Email: sylee[@]immuneoncia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 SIRPa 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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Biological:
• IMC-002
IMC-002 blocks the interaction between CD47 and SIRPa.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, Republic of Korea	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneOncia Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose-Limiting Toxicities (DLTs)		21 days
Primary	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