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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-Hodgkin Lymphoma
- Sponsor
- Spectrum Pharmaceuticals, Inc
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
Time Frame: Weekly for 6 months
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 Outcomes
- 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)