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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682796
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 18, 2020
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

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

Locations
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United States, Arizona
Banner MD Anderson Recruiting
Gilbert, Arizona, United States, 85234
Contact: Amanda Standford, RN    480-256-5462    Amanda.Stanford@bannerhealth.com   
Principal Investigator: Javier Munoz, MD         
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Ceonne Kim    858-822-0201    cek008@ucsd.edu   
Principal Investigator: Natalie Galanina, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Damayanti Bhavsar    732-235-6008    bhavsadm@cinj.rutgers.edu   
Principal Investigator: Rajat Bannerji, MD, PhD         
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Jenna Nichols    716-845-4359    jenna.nichols@roswellpark.org   
Principal Investigator: Francisco J. Hernandez-Ilizaliturri, MD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Hemakatha Rao    614-685-1976    hemalatha.rao@osumc.edu   
Principal Investigator: Beth Christian, MD         
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael McNicholas, RN       Michael.McNicholas@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: Rashvi Patel    416-946-4501 ext 3190    rashvi.patel@uhn.ca   
Principal Investigator: John Kuruvilla, MD, FRCPC         
Canada, Quebec
Jewish General Hospital Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Chadi Zakaria, PhD    514-340-8222 ext 28326    chadi.zakaria.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Sarit Assouline, MD         
Sponsors and Collaborators
Triphase Research and Development III Corp.
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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: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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