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

  • Clinicaltrials.gov identifier

    NCT03682796

  • Recruitment Status

    Recruiting

  • First Posted

    September 25, 2018

  • Last update posted

    April 1, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Non-Hodgkin
    Lymphoma, Mantle-Cell
    Lymphoma, Marginal Zone
    Lymphoma, Large B-Cell, Diffuse
    Lymphoma, Follicular
  • Intervention/Treatment: Drug: TRPH-222
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: August 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Escalation
Estimated to be <31 subjects across multiple centers
Drug: TRPH-222
administered by IV, 21-day Cycle
Experimental: Expansion
Estimated to be <121 subjects across multiple centers
Drug: TRPH-222
administered by IV, 21-day Cycle

Outcome Measures

  • Primary Outcome Measures: 1. Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]
    To determine the MTD of TRPH-222
  • Secondary Outcome Measures: 1. 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
  • 2. Tumor Activity [ Time Frame: Up to 2 years ]
    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
  • 3. 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 ]
    Maximum concentration of TRPH-222 (Cmax)
  • 4. 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 ]
    Time to Cmax
  • 5. 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 ]
    Half-life (t 1/2)
  • 6. 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 ]
    Exposure (area under the curve; AUC)
  • 7. 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 ]
    Total body clearance (CL)
  • 8. 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 ]
    Volume of distribution (Vd)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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) 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

Contacts and Locations

Contacts

Contact: Precision for Medicine 858-295-4326 Triphase_TRPH-222-100_Inquiries@precisionformedicine.com

Locations

United States, Arizona
Banner MD Anderson
Gilbert

United States, New York
Roswell Park Comprehensive Cancer Center
Buffalo

United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia

United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology
Nashville

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
Jewish General Hospital
Montréal

Sponsors and Collaborators

Triphase Research and Development III Corp.

More Information

  • Responsible Party: Triphase Research and Development III Corp.
  • ClinicalTrials.gov Identifier: NCT03682796 History of Changes
  • Other Study ID Numbers: TRPH-222-100
  • First Posted: September 25, 2018 Key Record Dates
  • Last Update Posted: April 1, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Triphase Research and Development III Corp.: Antibody-Drug Conjugate
    ADC
    CD22
    SMARTag™ technology
    TRPH-222
  • Additional relevant MeSH terms: Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Non-Hodgkin
    Lymphoma, Large B-Cell, Diffuse
    Lymphoma, Follicular
    Lymphoma, Mantle-Cell
    Neoplasms by Histologic Type
    Neoplasms
    Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases