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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-002 | Experimental | IMC-002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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] |
| through study completion, an average of 1 year |
| 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 |
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Inclusion Criteria:
Signed ICF
Adult (19 years or older)
Diagnosis and prior therapies
3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors
3-2. Part 2, HCC Cohort:
3-3. Part 2, TNBC Cohort:
3-4. Part 2, BTC Cohort:
3-5. Part 2, B-cell lymphoma Cohort:
Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:
Received ≥2 prior systemic therapies and eligible for rituximab treatment
Subject must have at least 1 measurable lesion by RECIST 1.1
Availability of tumor archival material or fresh biopsies
ECOG performance status 0 or 1 and life expectancy ≥3 months
Adequate hematologic function, hepatic function, and renal function
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
Agree to use effective contraception
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SUNG YOUNG LEE | Contact | +82 2 6283 5096 | sylee@immuneoncia.com |
| Name | Affiliation | Role |
|---|---|---|
| HEUNG TAE KIM, MD | ImmuneOncia Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Active, not recruiting | Goyang-si | South Korea | |||
| Asan Medical Center, Republic of Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 40841178 | 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. |
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Part 1: Dose Escalation Part 2: Expansion cohort
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|
| 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 |
| Completed |
| Seoul |
| South Korea |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| 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. |
| 41197525 | 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. |