Extranodal NK/T-cell Lymphoma, Extranodal NK/T-cell Lymphoma, Nasal Type
Conditions
Keywords
IMC-001, IMC-001-201, DISTINKT
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.
Interventions
DRUGIMC-001
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
Sponsors
ImmuneOncia Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Adult age(as defined by respective country) 3. The nature of the study and voluntarily sign an ICF 4. ECOG 0 or1 5. Adequate hematologic function, hepatic function, and renal function
Exclusion criteria
1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody 2. Known presence of symptomatic CNS metastases 3. Prior allogeneic HSCT or solid organ transplantation 4. Any active autoimmune disease or a documented history of autoimmune disease 5. Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus 6. Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Objective Response Rate(ORR) | through study completion, an average of 1 year | Lugano criteria with LYRIC modification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 : 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 criteria |
| Evaluate 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 criteria |
| Evaluate 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 criteria |
| Evaluate 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 criteria |
| Evaluate 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 criteria |
| Evaluate 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 criteria |
| 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) |
| Determine 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORWon Seog Kim
Samsung Medical Center, Republic of Korea
Outcome results
None listed