Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects (NHL)
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|ClinicalTrials.gov Identifier: NCT02519270|
Recruitment Status : Suspended
First Posted : August 10, 2015
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin Lymphoma||Biological: IGN002||Phase 1|
This open-label, non-randomized, first-in-human Phase 1 study involves two stages:
In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.
In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.
|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, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)|
|Actual Study Start Date :||May 1, 2016|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||January 2025|
Experimental: Dose Escalation Stage/ Expansion Stage
The Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002.
In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the maximum tolerated dose administered weekly in three 8-week cycles.
IGN002 is a monoclonal antibody fusion protein.
- To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL [ Time Frame: Weekly for 6 months ]Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the maximum tolerated dose
- To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly [ Time Frame: Weekly for 6 months ]Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL)
- To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL [ Time Frame: Every 8 weeks for 6 months, then at 1, 3 and 6 months ]Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
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): NCT02519270
|United States, California|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||John Timmerman||University of California, Los Angeles|