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

Spectrum Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Non-Hodgkin Lymphoma

Treatments: Biological: IGN002

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02519270

IGN002-101

Details and patient eligibility

About

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)

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Dose Escalation Stage/ Expansion Stage

Experimental group

Description:

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.

Treatment:

Biological: IGN002