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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IGN002
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCLA
  • UPMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation Stage/ Expansion Stage

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.

Full Information

First Posted
August 3, 2015
Last Updated
February 23, 2022
Sponsor
Spectrum Pharmaceuticals, Inc
Collaborators
The Leukemia and Lymphoma Society
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1. Study Identification

Unique Protocol Identification Number
NCT02519270
Brief Title
Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects
Acronym
NHL
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic Reasons
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
Collaborators
The Leukemia and Lymphoma Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Stage/ Expansion Stage
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
IGN002
Intervention Description
IGN002 is a monoclonal antibody fusion protein.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
Description
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 Outcome Measure Information:
Title
To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly
Description
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
Title
To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UCLA
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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