A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
- Conditions
- Extranodal NK/T-cell LymphomaExtranodal NK/T-cell Lymphoma, Nasal Type
- Interventions
- Registration Number
- NCT04414163
- Lead Sponsor
- ImmuneOncia Therapeutics Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 23
-
ENKTL diagnosis;
- Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type
- At least 1 previous line of systemic therapy
- Documented disease progression of last therapy
-
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
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic CNS metastases
- Prior allogeneic HSCT or solid organ transplantation
- Any active autoimmune disease or a documented history of autoimmune disease
- Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMC-001 IMC-001 Single Dose level (IMC-001 20mg/kg, every 2 weeks)
- Primary Outcome Measures
Name Time Method Occurrence of Objective Response Rate(ORR) through study completion, an average of 1 year Lugano criteria with LYRIC modification
- Secondary Outcome Measures
Name Time Method Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate 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. Complete Response (CR) rate, (Unit of Measure: Percentage of participants)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
3. based on response as determined by the investigator per the Lugano criteriaEvaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR) 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. Disease Control Rate (DCR), (Unit of Measure: Percentage of participants)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteriaEvaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS) 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. Progression-Free Survival (PFS), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
3. based on response as determined by the investigator per the Lugano criteriaEvaluate additional efficacy variables of IMC-001 : Duration of Response (DOR) 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. Duration of Response (DOR), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteriaEvaluate additional efficacy variables of IMC-001 : Time to Progression (TTP) 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. Time to Progression (TTP), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteriaEvaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR) 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. Overall Response Rate (ORR), (Unit of Measure: Percentage of participants)
1. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteriaDetermine the pharmacokinetic (PK) profile of IMC-001 : Ctrough 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) The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points.
Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax 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) The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval.
Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA) 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) 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.
Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug 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) 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.
Evaluate safety of IMC-001 through study completion, an average of 1 year Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001
Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS) through study completion, an average of 1 year Overall Survival (OS), (Unit of Measure: Months)
Trial Locations
- Locations (5)
Chonnam National University Hwasun Hospital
🇰🇷Gwangju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Chonnam National University Hwasun Hospital🇰🇷Gwangju, Korea, Republic of