NCT03682796
Recruiting
September 25, 2018
April 1, 2021
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.
N/A
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 |
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
Contact: Precision for Medicine 858-295-4326 Triphase_TRPH-222-100_Inquiries@precisionformedicine.com
United States, Arizona
Banner MD Anderson
Gilbert
United States, New York
Roswell Park Comprehensive Cancer Center
Buffalo
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology
Nashville
Canada, Ontario
Princess Margaret Cancer Centre
Toronto
Canada, Quebec
Jewish General Hospital
Montréal
Triphase Research and Development III Corp.