Non-Hodgkin Lymphoma
Conditions
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.
Interventions
BIOLOGICALIGN002
IGN002 is a monoclonal antibody fusion protein.
Sponsors
The Leukemia and Lymphoma Society
Spectrum Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed