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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
administered by IV, 21-day Cycle
Banner MD Anderson
Gilbert, Arizona, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Maximum Tolerated Dose (MTD)
To determine the MTD of TRPH-222
Time frame: 21 days
Evaluate incidence and severity of AEs, serious AEs, TRPH-222-related AEs, AEs leading to death or discontinuation from treatment
Safety
Time frame: Up to 28 days after last dose of study drug
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
Time frame: Up to 2 years
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)
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
TRPH-222 anti-drug antibodies (ADA)
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
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Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada