- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414163
A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
April 10, 2024 updated by: ImmuneOncia Therapeutics Inc.
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
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
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JiEun Oh
- Phone Number: +82 31 707 8133
- Email: IOCSO@immuneoncia.com
Study Contact Backup
- Name: MinYoung Son
- Phone Number: +82 31 707 8133
- Email: IOCSO@immuneoncia.com
Study Locations
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Gwangju, Korea, Republic of
- Chonnam National University Hwasun Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Samsung Medical Center
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Ulsan, Korea, Republic of
- Ulsan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMC-001
Single Dose level (IMC-001 20mg/kg, every 2 weeks)
|
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Objective Response Rate(ORR)
Time Frame: 1 year (Not confirmed yet)
|
Lugano criteria with LYRIC modification
|
1 year (Not confirmed yet)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Won Seog Kim, Samsung Medical Center, Republic of Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2020
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
May 29, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMC-001-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extranodal NK/T-cell Lymphoma, Nasal Type
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedExtranodal NK/T-cell Lymphoma, Nasal TypeChina
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Ruijin HospitalUnknownNasal Type Extranodal NK/T-Cell LymphomaChina
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Sun Yat-sen UniversityEli Lilly and Company; Hoffmann-La RocheUnknownExtranodal NK/T-cell Lymphoma, Nasal TypeChina
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Fudan UniversityTerminatedExtranodal NK/T-cell Lymphoma, Nasal TypeChina
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Beijing Tongren HospitalNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal Type
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Jiangsu HengRui Medicine Co., Ltd.UnknownExtranodal NK/T-cell Lymphoma, Nasal TypeChina
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Ruijin HospitalCompletedNasal Type Extranodal NK/T-Cell LymphomaChina
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Samsung Medical CenterConsortium for Improving Survival of Lymphoma; Lymphoma Study Association; Deok-Hwan... and other collaboratorsCompletedExtranodal NK/T-cell Lymphoma, Nasal TypeKorea, Republic of
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Samsung Medical CenterAsan Medical Center; Yonsei University; Seoul National University; Chonnam National...CompletedExtranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypeKorea, Republic of
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Sun Yat-sen UniversityNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal TypeChina
Clinical Trials on IMC-001
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ImmuneOncia Therapeutics Inc.Not yet recruitingA Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (TMB-H)TMB-H | Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
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ImmuneOncia Therapeutics Inc.CompletedSolid Tumor | Metastasis | Locally AdvancedKorea, Republic of
-
Asan Medical CenterRecruitingSubjects With Resectable and Localized Gastric Cancer | Subjects With Resectable Esophageal Cancer or Liver Cancer | Subjects With Resectable Liver CancerKorea, Republic of
-
Sorrento Therapeutics, Inc.WithdrawnDiffuse Large B Cell Lymphoma | Biliary Tract Cancer | Peripheral T Cell Lymphoma | Extranodal NK T Cell Lymphoma, Nasal
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMelanoma | Metastatic Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Metastatic MelanomaUnited States
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Eli Lilly and CompanyCompletedMalignant MelanomaUnited States
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Innovative Med Concepts, LLCCompletedChronic Pain | Fibromyalgia | Myofascial PainUnited States
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ImmuneOncia Therapeutics Inc.CompletedLymphoma | Solid TumorKorea, Republic of, United States
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ImmuneOncia Therapeutics Inc.RecruitingAdvanced CancerKorea, Republic of
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Toll Biotech Co. Ltd. (Beijing)Recruiting