Description:
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)
Title
- Brief Title: Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects
- 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 IDs
- ORG STUDY ID:
IGN002-101
- NCT ID:
NCT02519270
Conditions
Interventions
Drug | Synonyms | Arms |
---|
IGN002 | | Dose Escalation Stage |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation Stage | Experimental | The Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002. | |
Expansion Stage | Experimental | 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 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
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 |
Secondary Outcome Measures
Measure: | To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly |
Time Frame: | Weekly for 6 months |
Safety Issue: | |
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) |
Measure: | To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL |
Time Frame: | Every 8 weeks for 6 months, then at 1, 3 and 6 months |
Safety Issue: | |
Description: | Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ImmunGene, Inc. |
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