A Study of IGN002 for Refractory NHL

NCT02847949 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IGN002-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.

Conditions

NHL

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL

  Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002

  An average of 1 year.

Secondary Outcomes (2)

• Duration of response to IGN002 using the Lugano Classification for NHL

  Through study completion, an average of 1 year.

• Overall response rate of the therapeutic agent in NHL patients.

  Through study completion, an average of 1 year.

Study Arms (1)

Extension arm

EXPERIMENTAL

IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Spectrum sponsored IGN002 study, IGN002-101.

Biological: IGN002

Interventions

IGN002 BIOLOGICAL

IGN002 is a monoclonal antibody fusion protein

Extension arm

Eligibility Criteria

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

You may qualify if:

• Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101
• Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study
• Tolerated IGN002 therapy in the other Spectrum sponsored IGN002 study
• Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
• Able and willing to provide informed consent

You may not qualify if:

• Discontinued from other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment
• Experienced PD during participation in other Spectrum sponsored study, IGN002-101
• Pregnant or nursing
• Concurrent medical condition that precludes safe participation in this study
• Active viral hepatitis infection. Subjects with history of hepatitis infection that is not active are eligible.

Sponsors & Collaborators

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

Study Sites (1)

UCLA

Santa Monica, California, 90404, United States

Location

Study Officials

• John Timmerman

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: July 12, 2016
• First Posted: July 28, 2016
• Study Start: January 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)