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

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

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

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