Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/10/2018 |
Start Date: | December 2015 |
End Date: | December 2018 |
Contact: | Clinical Operations |
Email: | clinical@immungene.com |
Phone: | (877) 777-9233 |
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)
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)
Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with
Refractory Non-Hodgkin Lymphoma (NHL)
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.
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.
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
We found this trial at
3
sites
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Nam Dang, MD
Phone: 352-273-7832
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Houston, Texas 77030
Principal Investigator: Loretta Nastoupil, MD
Phone: 713-794-3074
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