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

Non-Hodgkin Lymphoma Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02519270
• Other study ID #: IGN002-101
• Status: Terminated
• Phase: Phase 1
• Start date: May 1, 2016
• Est. completion date: May 4, 2018

Study information

• Verified date: February 2022
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Biological:
• IGN002
IGN002 is a monoclonal antibody fusion protein.

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania
United States	UCLA	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Weekly for 6 months
Secondary	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.	Every 8 weeks for 6 months, then at 1, 3 and 6 months