Trial record 1 of 1 for:
OSE-279
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
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ClinicalTrials.gov Identifier: NCT05751798 |
Recruitment Status :
Recruiting
First Posted : March 2, 2023
Last Update Posted : March 2, 2023
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Sponsor:
OSE Immunotherapeutics
Information provided by (Responsible Party):
OSE Immunotherapeutics
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 30, 2023 | ||||||||
First Posted Date ICMJE | March 2, 2023 | ||||||||
Last Update Posted Date | March 2, 2023 | ||||||||
Actual Study Start Date ICMJE | December 20, 2022 | ||||||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Occurrence of dose limiting toxicity (DLT) [ Time Frame: DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279 (Cycle 1) ] Occurrence of dose limiting toxicity (DLT)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas | ||||||||
Official Title ICMJE | A Multicenter, Phase 1/2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas | ||||||||
Brief Summary | This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
24 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2024 | ||||||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria (I):
Non-Inclusion Criteria (NI):
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05751798 | ||||||||
Other Study ID Numbers ICMJE | OSE-279-C101 2022-001136-28 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | OSE Immunotherapeutics | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | OSE Immunotherapeutics | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | OSE Immunotherapeutics | ||||||||
Verification Date | February 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |