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

NCT ID: NCT02519270

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2018-05-04

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation Stage/ Expansion Stage

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.

Group Type: EXPERIMENTAL

IGN002

Intervention Type: BIOLOGICAL

IGN002 is a monoclonal antibody fusion protein.

Interventions

IGN002

IGN002 is a monoclonal antibody fusion protein.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leukemia and Lymphoma Society

OTHER

Sponsor Role: collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLA

Santa Monica, California, United States

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

IGN002-101

Identifier Type: -

Identifier Source: org_study_id