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

Primary Purpose

Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TRPH-222
Sponsored by
Triphase Research and Development III Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Antibody-Drug Conjugate, ADC, CD22, SMARTag™ technology, TRPH-222

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson
  • Roswell Park Comprehensive Cancer Center
  • Ohio State University Comprehensive Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Sarah Cannon Research Institute at Tennessee Oncology
  • Princess Margaret Cancer Centre
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Escalation

Expansion

Arm Description

Estimated to be <31 subjects across multiple centers

Estimated to be <121 subjects across multiple centers

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)
To determine the MTD of TRPH-222

Secondary Outcome Measures

Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment
Safety
Tumor Activity
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
TRPH-222 Pharmacokinetics (PK)
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)
TRPH-222 anti-drug antibodies (ADA)
Assess the incidence of subjects who develop ADA to the ADC with TRPH-222 monotherapy

Full Information

First Posted
September 20, 2018
Last Updated
May 13, 2022
Sponsor
Triphase Research and Development III Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT03682796
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Triphase Research and Development III Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
Keywords
Antibody-Drug Conjugate, ADC, CD22, SMARTag™ technology, TRPH-222

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escalation
Arm Type
Experimental
Arm Description
Estimated to be <31 subjects across multiple centers
Arm Title
Expansion
Arm Type
Experimental
Arm Description
Estimated to be <121 subjects across multiple centers
Intervention Type
Drug
Intervention Name(s)
TRPH-222
Intervention Description
administered by IV, 21-day Cycle
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
To determine the MTD of TRPH-222
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment
Description
Safety
Time Frame
Up to 28 days after last dose of study drug
Title
Tumor Activity
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
Time Frame
Up to 2 years
Title
TRPH-222 Pharmacokinetics (PK)
Description
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)
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
Title
TRPH-222 anti-drug antibodies (ADA)
Description
Assess the incidence of subjects who develop ADA to the ADC with TRPH-222 monotherapy
Time Frame
Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Hernandez- Ilizaliturri, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner MD Anderson
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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