Actively Recruiting

Phase 1
Age: 19Years +
All Genders
NCT05276310

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

Led by ImmuneOncia Therapeutics Inc. · Updated on 2026-04-24

62

Participants Needed

3

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Adults aged 19 years or older
  • Histologically or cytologically confirmed metastatic or locally advanced solid tumors (Part 1)
  • For hepatocellular carcinoma cohort: confirmed hepatocellular carcinoma, prior systemic therapy received, lenvatinib-naive, Child Pugh classification A
  • For triple negative breast cancer cohort: confirmed triple negative breast cancer, prior systemic regimen received, eligible for paclitaxel or gemcitabine/carboplatin, and no recent use of planned standard chemotherapy unless relapse after 6 months
  • For biliary tract cancer cohort: confirmed biliary tract cancer, prior systemic therapy received, lenvatinib-naive
  • For B-cell lymphoma cohort: confirmed CD20+ mature B-cell lymphoma, received at least two prior systemic therapies, eligible for rituximab treatment
  • At least one measurable tumor lesion by RECIST 1.1
  • Availability of tumor tissue for analysis
  • ECOG performance status of 0 or 1 and life expectancy of at least 3 months
  • Adequate blood, liver, and kidney function
  • Prior radiotherapy allowed if completed at least 4 weeks before treatment and disease measurable outside radiotherapy field or progressed post-radiotherapy
  • Agreement to use effective contraception
  • Willingness and ability to follow study visits, treatment, and testing procedures
Not Eligible

You will not qualify if you...

  • Use of nonpermitted drugs
  • Prior treatment with CD47 or SIRPα targeting agents
  • Receiving other anticancer treatments concurrently
  • Major surgery or significant injury before screening or planned major surgery during the study
  • History of other malignancies besides the current study cancer
  • Active infection needing systemic therapy before treatment start
  • Active or history of autoimmune disease
  • Psychiatric or cognitive conditions that interfere with study participation
  • Known severe allergic reactions
  • Pregnancy or breastfeeding
  • Participation in another clinical trial currently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

National Cancer Center

Goyang-si, South Korea

Active, Not Recruiting

2

Asan Medical Center, Republic of Korea

Seoul, South Korea

Completed

3

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

S

SUNG YOUNG LEE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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