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

Stopped early · Phase 1

Conditions studied: Non-Hodgkin Lymphoma

In brief

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)

Key facts

Study ID

NCT02519270

Run by

Spectrum Pharmaceuticals, Inc

People needed

62

Starts

2016-05-01

Expected to finish

2018-05-04

Last updated by the study team

2022-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
• Refractory disease, having failed available therapies
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy > 3 months
• Adequate organ function

You may not qualify if…

• Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
• Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
• Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
• Radiation therapy within 4 weeks of Day 1

Where it is running

• UCLA — Santa Monica, California, United States
• UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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