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

Phase 1TerminatedNCT02519270

Spectrum Pharmaceuticals, Inc62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin Lymphoma

Interventions

IGN002BIOLOGICAL

IGN002 is a monoclonal antibody fusion protein.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

UCLA

Santa Monica, California, United States

UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL

Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the maximum tolerated dose

Time frame: Weekly for 6 months

Secondary Outcomes

To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly

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)

Time frame: Weekly for 6 months

To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL

Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.

Time frame: Every 8 weeks for 6 months, then at 1, 3 and 6 months

Data from ClinicalTrials.gov

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