Trial | NCT02519270  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    ign002 ...

  • Study Participants

    62
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)
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 Started
May 01
2016
Primary Completion
May 04
2018
Study Completion
May 04
2018
Last Update
Mar 11
2022

Biological IGN002

IGN002 is a monoclonal antibody fusion protein.

Dose Escalation Stage/ Expansion Stage Experimental

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.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted