Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- Biological: IGN002
- Registration Number
- NCT02519270
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation Stage/ Expansion Stage IGN002 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.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL 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 Outcome Measures
Name Time Method To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly Weekly for 6 months 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 Every 8 weeks for 6 months, then at 1, 3 and 6 months Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
Trial Locations
- Locations (2)
UCLA
🇺🇸Santa Monica, California, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States