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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682796
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Triphase Research and Development III Corp.

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 Intervention/treatment Phase
Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Lymphoma, Marginal Zone Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Drug: TRPH-222 Phase 1

Detailed Description:
In Dose Escalation, patients with DLBCL, FL (including transformed FL), MZL, and MCL were to be enrolled per dose cohort. In Dose Expansion, additional response-evaluable patients were to be enrolled in NHL subtype-specific cohorts including DLBCL and FL to confirm the RP2D identified in Escalation. Each stage consisted of screening, baseline, treatment, and follow-up periods. During the treatment period, patients were to be treated indefinitely in 21 day cycles. The EOT assessments were to occur 28 and 60 days after the last study treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : November 17, 2021
Actual Study Completion Date : November 17, 2021


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




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), time to Cmax, Half-life (t 1/2), Exposure (area under the curve; AUC), Total body clearance (CL), Volume of distribution (Vd)

  4. TRPH-222 anti-drug antibodies (ADA) [ Time Frame: Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60 ]
    Assess the incidence of subjects who develop ADA to the ADC with TRPH-222 monotherapy



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682796


Locations
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United States, Arizona
Banner MD Anderson
Gilbert, Arizona, United States, 85234
United States, New York
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States, 37203
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Triphase Research and Development III Corp.
Investigators
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Principal Investigator: Francisco J Hernandez- Ilizaliturri, MD Roswell Park Cancer Institute
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Responsible Party: Triphase Research and Development III Corp.
ClinicalTrials.gov Identifier: NCT03682796    
Other Study ID Numbers: TRPH-222-100
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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