NCT03682796

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 lymphoma

Timeline
Completed

Started Oct 2018

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

September 20, 2018

Last Update Submit

May 13, 2022

Conditions

LymphomaLymphoma, B-CellLymphoma, Non-HodgkinLymphoma, Mantle-CellLymphoma, Marginal ZoneLymphoma, Large B-Cell, DiffuseLymphoma, Follicular

Keywords

Antibody-Drug ConjugateADCCD22SMARTag™ technologyTRPH-222

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    To determine the MTD of TRPH-222

    21 days

Secondary Outcomes (4)

  • Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment

    Up to 28 days after last dose of study drug

  • Tumor Activity

    Up to 2 years

  • TRPH-222 Pharmacokinetics (PK)

    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

  • TRPH-222 anti-drug antibodies (ADA)

    Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60

Study Arms (2)

Escalation

EXPERIMENTAL

Estimated to be \<31 subjects across multiple centers

Drug: TRPH-222

Expansion

EXPERIMENTAL

Estimated to be \<121 subjects across multiple centers

Drug: TRPH-222

Interventions

TRPH-222DRUG

administered by IV, 21-day Cycle

EscalationExpansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Banner MD Anderson

Gilbert, Arizona, 85234, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43219, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

LymphomaLymphoma, B-CellLymphoma, Non-HodgkinLymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseLymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Francisco J Hernandez- Ilizaliturri, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 25, 2018

Study Start

October 15, 2018

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(5)CA(2)