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This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-001 | Experimental | Single Dose level (IMC-001 20mg/kg, every 2 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-001 | Drug | Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Objective Response Rate(ORR) | Lugano criteria with LYRIC modification | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of IMC-001 | Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001 | through study completion, an average of 1 year |
| Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate |
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Inclusion Criteria:
ENKTL diagnosis;
Adult age(as defined by respective country)
The nature of the study and voluntarily sign an ICF
ECOG 0 or1
Adequate hematologic function, hepatic function, and renal function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim | Samsung Medical Center, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Gwangju | South Korea | ||||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | W.S.Kim, et al. AI-Based Membrane Specific PD-L1 and Tumor Immune Microenvironment as Predictive Biomarkers for Danburstotug in Relapsed or Refractory Extranodal NK/T cell Lymphoma (R/R ENKTL): Insights from A Phase II Trial (DISTINKT). ICKSH; 2026; Seoul, Korea; AK-0083. | ||
| Background | W.S.Kim, et al. AI-based membrane specific PD-L1 and tumor immune microenvironment (TIME) subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). T-cell lymphoma forum; 2026; San Diego, California, USA; TCLF38. | ||
| Background | W.S.Kim, et al. Artificial intelligence (AI)-based membrane specific PD-L1 and immune subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). ASH; 2025; Orlando, USA; 5426. | ||
| Background | T.W.Sung, et al. Optimizing IMC-001 Dosage Regimens Using Target Mediated Drug Disposition Model: Enhancing Therapeutic Efficacy and Safety in Cancer Treatment. PAGE; 2024; Rome, Italy; Abstract 10927. | ||
| Background | W.S.Kim, et al. ENHANCED EFFICACY AND SAFETY FROM PHASE 2 STUDY OF IMC-001, ANTI-PD-L1 ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY EXTRANODAL NK/T CELL LYMPHOMA (R/R ENKTL), NASAL TYPE: DISTINKT STUDY. EHA; 2024; Madrid, Spain; P1213. | ||
| Background |
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Complete Response (CR) rate, (Unit of Measure: Percentage of participants)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR) | Disease Control Rate (DCR), (Unit of Measure: Percentage of participants)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS) | Progression-Free Survival (PFS), (Unit of Measure: Months)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR) | Duration of Response (DOR), (Unit of Measure: Months)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP) | Time to Progression (TTP), (Unit of Measure: Months)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR) | Overall Response Rate (ORR), (Unit of Measure: Percentage of participants)
| The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator. |
| Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS) | Overall Survival (OS), (Unit of Measure: Months) | through study completion, an average of 1 year |
| Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough | The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points. | Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days) |
| Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax | The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval. | Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days) |
| Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA) | Incidence of anti-drug antibody (ADA) (including serum titers of anti-IMC-001 antibodies) The percentage of patients demonstrating anti-IMC-001 antibodies will be calculated. | Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit) |
| Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity | Correlation Between ADA and Drug Exposure and Activity The Spearman nonparametric correlation coefficient will be calculated to quantify the relationship between titer of anti-IMC-001 antibodies and exposure and activity. | Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit) |
| Seoul |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| J.H.Jeon, et al. Exposure-response (E-R) relationship between PD-L1 recombinant monoclonal antibody IMC-001 in relapsed or refractory extranodal NK/T cell lymphoma nasal type patients. ACoP; 2024; Phoenix, Arizona, USA; T-058. |
| Background | W.S.Kim, et al. Phase 2 study to investigate the efficacy and safety of IMC-001, anti-PD-L1 antibody, in Patients with relapsed or refractory extranodal NK/T Cell lymphoma, nasal Type: DISTINKT Study. ICML; 2023; Lugano, Switzerland; Abstract 433. |
| Background | W.S.Kim, et al. Efficacy and Safety of IMC-001, anti-PD-L1 antibody, in Patients with Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (R/R ENKTL). ESMO; 2022; Singapore, Republic of Singapore; Abstract 494. |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722928 | IMC-001 |
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