NCT02519270

Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	IGN002	IGN002 is a monoclonal antibody fusion protein.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2015-08-10
• Last updated: 2022-03-11

Locations

2 sites across 1 country: United States