Clinical Trials /

Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects

NCT02519270

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)

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02519270

Trial Eligibility

Document

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

  • Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
IGN002Dose Escalation Stage/ Expansion 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

NameTypeDescriptionInterventions
Dose Escalation Stage/ Expansion StageExperimentalThe Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002. 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.
  • IGN002

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:Spectrum Pharmaceuticals, Inc

Last Updated

June 15, 2021