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

NCT05276310 | Recruiting Phase 1 DMC

• 1 other identifier: IMC-002-K102
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced Cancer

Keywords

IMC-002; Phase I; CD47; SIRPα

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs)

  To determine maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002

  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 * Immunogenicity: anti-IMC-002 antibody

  through study completion, an average of 1 year

Secondary Outcomes (19)

• Pharmacokinetics Endpoint : Cmax

  through study completion, an average of 1 year

• Pharmacokinetics Endpoint : Ctrough

  through study completion, an average of 1 year

• Pharmacokinetics Endpoint : Tmax

  through study completion, an average of 1 year

• Pharmacokinetics Endpoint : AUC

  through study completion, an average of 1 year

• Pharmacokinetics Endpoint : CL

  through study completion, an average of 1 year

Study Arms (1)

IMC-002

EXPERIMENTAL

IMC-002

Biological: IMC-002

Interventions

IMC-002 BIOLOGICAL

Part 1: Dose escalation IMC-002 5, 10, 20, and 30 mg/kg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg/kg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg/m2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg/m2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg/m2 IV infusion on Day 1 of each cycle

IMC-002

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed ICF
• Adult (19 years or older)
• Diagnosis and prior therapies
• Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors
• Part 2, HCC Cohort:
• Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)
• Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.
• Child Pugh classification A
• Part 2, TNBC Cohort:
• Histologically or cytologically proven metastatic or locally advanced of triple negative breast cancer: negative of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2)
• Received ≥1 prior systemic regimen and eligible for paclitaxel or gemcitabine/carboplatin. Patients who have previously received the planned SOC in this study (paclitaxel or gemcitabine/carboplatin) cannot be enrolled. If at least 6 months have elapsed since the completion of a prior SOC (paclitaxel, gemcitabine, and/or carboplatin) and the patient showed a tumor response to that regimen, the same SOC can be used in this trial.
• Bisphosphonate or denosumab for bone metastases is allowed if started before Cycle 1 Day 1. Prophylactic use of bisphosphonates or denosumab in patients without bone diseases is not permitted, except for the treatment of osteoporosis.
• Part 2, BTC Cohort:
• Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)
• Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneOncia Therapeutics Inc.: lead

Study Sites (3)

National Cancer Center

Goyang-si, South Korea

ACTIVE NOT RECRUITING

Asan Medical Center, Republic of Korea

Seoul, South Korea

COMPLETED

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (8)

• J.S.Ahn, et al. Enhanced Safety Profile of IMC-002, an Affinity-Optimized Anti-CD47 Antibody: Preclinical and Phase 1a/1b Findings. ESMO; 2025; Berlin, Germany. Abstract 1554P.

  BACKGROUND

• J.Y.Hong, et al. Phase 1b Dose Extension Study of a Next-Generation Anti-CD47 Monoclonal Antibody IMC-002 Combined with Lenvatinib in Patients with Advanced Hepatocellular Carcinoma (HCC). ASCO; 2025; Chicago, IL, USA. Abstract 2526.

  BACKGROUND

• Jiyea Choi, et al. Development of IMC-002, a next-generation anti-CD47 mAb: An affinity optimized antibody with enhanced safety and therapeutic efficacy in preclinical models. AACR; 2025; Chicago, IL, USA.. Abstract 4789.

  BACKGROUND

• Seongmee Jeong, et al. Model informed dosage regimen optimization of anti-CD47 antibody using target mediated drug disposition model. PAGE; 2024; Rome, Italy. Abstract 10928.

  BACKGROUND

• H.Y.Lim, et al. Updated Safety, Efficacy, Pharmacokinetics, and Biomarkers from The Phase 1 Study of IMC-002, a Novel Anti-CD47 Monoclonal Antibody, in Patients with Advanced Solid Tumors. ASCO; 2024; Chicago, IL, USA. Abstract 2642.

  BACKGROUND

• H.Y.Lim, et al. Phase 1 dose escalation study of IMC-002, a novel anti-CD47 monoclonal antibody, in patients with advanced solid tumors. ESMO; 2023; Madrid, Spain. Abstract 1035P.

  BACKGROUND

• Jeong S, Lee SY, Kim SH, Kim HT, Yun HY, Chae JW, Lee S. Model-Informed Optimal Dosing of Anti-CD47 Antibody Using Target-Mediated Drug Disposition Model. Clin Transl Sci. 2025 Aug;18(8):e70321. doi: 10.1111/cts.70321.

  PMID: 40841178 BACKGROUND

• Ahn JS, Hong JY, Park JO, Lee SY, Kim S, Yun HY, Ock CY, Hwang W, Kim SH, Kim HT, Lim HY. Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors. Cancer Res Treat. 2025 Nov 4. doi: 10.4143/crt.2025.820. Online ahead of print.

  PMID: 41197525 BACKGROUND

Study Officials

• HEUNG TAE KIM, MD

  ImmuneOncia Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

SUNG YOUNG LEE

CONTACT

+82 2 6283 5096; sylee@immuneoncia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Dose Escalation Part 2: Expansion cohort

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 11, 2022
• Study Start: June 2, 2022
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): August 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)