Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by John Timmerman (ucla)

Description

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)

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)

Details

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.

Keywords

Non-Hodgkin Lymphoma Lymphoma Lymphoma, Non-Hodgkin IGN002

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UCLA
    Santa Monica California 90404 United States

Lead Scientist at UC Health

  • John Timmerman (ucla)
    Professor, Medicine. Authored (or co-authored) 59 research publications.

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Spectrum Pharmaceuticals, Inc
ID
NCT02519270
Phase
Phase 1
Study Type
Interventional
Last Updated