Protocol Summary

Protocol No.: OCR14387

Sponsor Protocol No.: IGN002-101; Valor

Study 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)

Principal Investigator(s)
Dang, Nam

Objective
The main purpose of this study is to test the safety of IGN002 at different dose levels.

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.

Phase: Phase I

Age Group: Adult

Scope: National

Treatment
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.

Detailed Eligibility
INCLUSION CRITERIA:
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

EXCLUSION CRITERIA:
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

Participating Institutions
UF Gainesville : Ashton Monismith

Contact
Ashton Monismith, RN
Phone: +1 352-265-0680 ext. 87657

Email: amonismith@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02519270