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

NCT02519270 | Terminated Phase 1

• 1 other identifier: IGN002-101
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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)

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  Weekly for 6 months

Secondary Outcomes (2)

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

  Weekly for 6 months

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

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

Study Arms (1)

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.

Biological: IGN002

Interventions

IGN002 BIOLOGICAL

IGN002 is a monoclonal antibody fusion protein.

Dose Escalation Stage/ Expansion Stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (2)

UCLA

Santa Monica, California, 90404, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 10, 2015
• Study Start: May 1, 2016
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)