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

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ClinicalTrials.gov Identifier: NCT03682796
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 11, 2019
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : August 30, 2022


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)

  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)



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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) 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.

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


Contacts
Contact: Precision for Medicine 858-295-4328 Triphase_TRPH-222-100_Inquiries@precisionformedicine.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph Vena, RN       Joseph.vena@uphs.upenn.edu   
Contact: Tanya Latorre, RN       Tanya.Latorre@uphs.upenn.edu   
Principal Investigator: Daniel J. Landsburg, MD         
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-339-4214    asksarah@sarahcannon.com   
Principal Investigator: Ian Flinn, MD         
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lisa Ye    416-946-4501 ext 2907    lisa.ye@uhn.ca   
Principal Investigator: John Kuruvilla, MD, FRCPC         
Sponsors and Collaborators
Triphase Research and Development III Corp.

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: January 11, 2019
Last Verified: January 2019
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