Clinical Trials /

Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma

NCT03682796

Description:

This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
  • Official Title: Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: TRPH-222-100
  • NCT ID: NCT03682796

Conditions

  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell
  • Lymphoma, Marginal Zone
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular

Interventions

DrugSynonymsArms
TRPH-222Escalation

Purpose

This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.

Trial Arms

NameTypeDescriptionInterventions
EscalationExperimentalEstimated to be <31 subjects across multiple centers
  • TRPH-222
ExpansionExperimentalEstimated to be <121 subjects across multiple centers
  • TRPH-222

Eligibility Criteria

        Inclusion Criteria

          -  Age ≥ 18 years at the time of signing the informed consent.

          -  Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL,
             FL (including transformed FL), MZL, or MCL.

          -  Relapsed and/or refractory NHL requiring systemic therapy and have failed, are
             intolerant to, or are considered ineligible for standard of care anticancer treatments
             that are known to be potentially curative. Subjects must not be current candidates for
             HSCT. Participants who refuse standard treatments may also be considered provided that
             documentation is provided that the subject has been made aware of all therapeutic
             options.

          -  Eastern Cooperative Oncology Group (ECOG) status 0-2.

        Exclusion Criteria

          -  Presence of a leukemic phase of the lymphoma.

          -  "Double hit" or "triple hit" germinal center B cell lymphoma

          -  Previous solid organ allograft (except for corneal transplant) or allogeneic
             bone-marrow transplant.

          -  Peripheral neuropathy > NCI-CTCAE Grade 1.

          -  Significant organ dysfunction that would preclude study participation.

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias

          -  Any other serious active disease or co-morbid medical condition, according to the
             Investigator's decision or Medical Monitor, that will substantially increase the risk
             associated with the subject's participation in the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD)
Time Frame:21 days
Safety Issue:
Description:To determine the MTD of TRPH-222

Secondary Outcome Measures

Measure:Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment
Time Frame:Up to 28 days after last dose of study drug
Safety Issue:
Description:Safety
Measure:Tumor Activity
Time Frame:Up to 2 years
Safety Issue:
Description:Assess tumor response - ORR for each NHL subtype using Lugano criteria, PFS from first dose to disease progression, OS from first dose to death, DOR for each NHL subtype assessed by Lugano
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Maximum concentration of TRPH-222 (Cmax)
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Time to Cmax
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Half-life (t 1/2)
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Exposure (area under the curve; AUC)
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Total body clearance (CL)
Measure:TRPH-222 Pharmacokinetics (PK)
Time Frame:Each Cycle is 21 days. Days 1, 8, 15 of Cycle 1; Day 1 of Cycle 2 and Cycle 3; Day 1 of every third cycle thereafter; up to Day 28 after last dose of study drug; Day 60 after last dose of study drug
Safety Issue:
Description:Volume of distribution (Vd)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Triphase Research and Development III Corp.

Trial Keywords

  • Antibody-Drug Conjugate
  • ADC
  • CD22
  • SMARTag™ technology
  • TRPH-222

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