A Study of IGN002 for Refractory NHL
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|ClinicalTrials.gov Identifier: NCT02847949|
Recruitment Status : Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|NHL||Biological: IGN002||Phase 1|
In this extension study, IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the Spectrum sponsored IGN002-101 study. If additional safety and PK data from another Spectrum sponsored IGN002 study support a higher dose level that is deemed safe and well tolerated by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered per Investigator discretion. Each treatment cycle comprises a total of 8 doses of IGN002 administered at weekly intervals.
Subjects will be evaluated at the study clinic before each dose of IGN002. At each study visit, standard of care assessments will be performed, which will include physical examination, measurement of vital signs, documentation of adverse events (AEs) and concomitant medications, and laboratory analyses of blood and urine. Radiological assessments will be performed at the end of each 8-week cycle. Tumor status will be assessed by comparison to the subject's baseline tumor status, as determined in the separate study, IGN002-101, or tumor nadir, if the subject has demonstrated response.
Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after the last dose of IGN002. This visit will include physical examination, vital sign measurements, laboratory analyses of blood and urine, and documentation of AEs and concomitant medications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Extension arm
IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Spectrum sponsored IGN002 study, IGN002-101.
IGN002 is a monoclonal antibody fusion protein
- To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL [ Time Frame: An average of 1 year. ]Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002
- Duration of response to IGN002 using the Lugano Classification for NHL [ Time Frame: Through study completion, an average of 1 year. ]Lugano Classification Criteria for NHL will be used to assess the duration of response to IGN002
- Overall response rate of the therapeutic agent in NHL patients. [ Time Frame: Through study completion, an average of 1 year. ]Overall response rate following IGN002 treatment will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847949
|Contact: Fabio Matavelifirstname.lastname@example.org|
|Contact: Lisia Lubianskyemail@example.com|
|United States, California|
|Santa Monica, California, United States, 90404|
|Contact: Nicole Sowden Williams 213-247-4788 firstname.lastname@example.org|
|Principal Investigator: John Timmerman, MD|
|Principal Investigator:||John Timmerman||University of California, Los Angeles|