Clinical trial NCT04414163: A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
Official title: An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Extranodal NK/T-cell Lymphoma
Keywords: IMC-001
IMC-001-201
DISTINKT
Lead sponsor: ImmuneOncia Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Objective Response Rate(ORR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluate safety of IMC-001
timeFrame: through study completion, an average of 1 year
measure: Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)
timeFrame: 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.
measure: Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)
timeFrame: through study completion, an average of 1 year
measure: Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough
timeFrame: 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)
measure: Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax
timeFrame: 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)
measure: Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)
timeFrame: 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)
measure: Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity
timeFrame: 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)
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Samsung Medical Center, Republic of Korea
name: Won Seog Kim
role: PRINCIPAL_INVESTIGATOR
References: