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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: IMC-002

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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SUNG YOUNG LEE; Phone Number: +82 2 6283 5096; Email: sylee@immuneoncia.com

Study Locations

• South Korea
  • Goyang-si, South Korea
    • Active, not recruiting
    • National Cancer Center
  • Seoul, South Korea
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Jung Yong Hong, MD
  • Seoul, South Korea
    • Completed
    • Asan Medical Center, Republic of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed ICF
2. Adult (19 years or older)

3. Diagnosis and prior therapies

   3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors

   3-2. Part 2, HCC Cohort:

   1. Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)
   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.
   3. Child Pugh classification A

   3-3. Part 2, TNBC Cohort:

   1. 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)
   2. 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.
   3. 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.

   3-4. Part 2, BTC Cohort:

   1. Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)
   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib

   3-5. Part 2, B-cell lymphoma Cohort:

   1. Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:

      • diffuse large B-cell lymphoma (de novo or transformed)
      • Mantle cell lymphoma
      • Follicular lymphoma
      • Marginal zone lymphoma (nodal, extranodal or mucosa associated)

   2. Received ≥2 prior systemic therapies and eligible for rituximab treatment

      • For all cancer type, neo-adjuvant and/or adjuvant chemotherapy is not regarded as chemotherapeutic regimen for metastatic or recurrent cancer unless recurrence within 6 months after the last dose of anti-cancer drugs as neo-adjuvant and/or adjuvant therapy.
4. Subject must have at least 1 measurable lesion by RECIST 1.1
5. Availability of tumor archival material or fresh biopsies
6. ECOG performance status 0 or 1 and life expectancy ≥3 months
7. Adequate hematologic function, hepatic function, and renal function
8. Prior RT permitted if measurable disease exists outside the RT field or if disease progressed post-RT. RT must be completed ≥4 weeks before Cycle 1 Day 1
9. Agree to use effective contraception
10. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IMC-002

Biological: IMC-002; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Endpoint : Cmax	maximum observed serum concentration (Cmax) of IMC-002	through study completion, an average of 1 year
Pharmacokinetics Endpoint : Ctrough	minimum observed serum concentration immediately before dosing (Ctrough) of IMC-002	through study completion, an average of 1 year
Pharmacokinetics Endpoint : Tmax	time of the maximum observed serum concentration (Tmax) of IMC-002	through study completion, an average of 1 year
Pharmacokinetics Endpoint : AUC	Area Under the Serum Concentration-Time Curve (AUC) of IMC-002	through study completion, an average of 1 year
Pharmacokinetics Endpoint : CL	total body clearance (CL) of IMC-002	through study completion, an average of 1 year
Pharmacokinetics Endpoint : t½	terminal half-life (t½) of IMC-002	through study completion, an average of 1 year
Efficacy endpoints based on tumor assessment (Part2) : BOR	best overall response (BOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : ORR	objective response rate (ORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : DCR	disease control rate (DCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : DOR	duration of response (DOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : TTP	time-to-progression (TTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : PFS	progression-free survival (PFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iBOR	Immune best overall response(iBOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iORR	Immune objective response rate(iORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iDCR	Immune disease control rate(iDCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iDOR	Immune duration of response(iDOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iTTP	Immune time-to-progression(iTTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : iPFS	Immune progression-free survival(iPFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).	Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.
Efficacy endpoints based on tumor assessment (Part2) : overall survival (OS)	overall survival (OS)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: ImmuneOncia Therapeutics Inc.
• Investigators: Study Director: HEUNG TAE KIM, MD, ImmuneOncia Therapeutics Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): August 30, 2029

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Phase I; CD47; SIRPα; IMC-002
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IMC-002-K102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No