Protocol No.: OCR14387
Sponsor Protocol No.: IGN002-101; Valor
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)
The main purpose of this study is to test the safety of IGN002 at different dose levels.
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.
Phase: Phase I
Age Group: Adult
Dose-escalation stage: subjects will receive up to 26 doses of IGN002.
Expansion stage: subjects will receive up to 24 doses of IGN002 at the maximum tolerated dose administered weekly in three 8-week cycles.
1. Ages 18 years-old and older
2. 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
3. Refractory disease, having failed available therapies
4. Measurable disease
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
6. Life expectancy > 3 months
7. Adequate organ function
1. Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
2. Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
3. Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
4. Radiation therapy within 4 weeks of Day 1
Applicable Disease Sites
Lymphoma - Non-Hodgkin
UF Gainesville : Ashton Monismith
Ashton Monismith, RN
Phone: +1 352-265-0680 ext. 87657
View study listing on ClinicialTrials.gov