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

Phase 1

Completed

• Conditions: Lymphoma, Marginal Zone; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Interventions: Drug: TRPH-222

• Registration Number: NCT03682796
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2018-10-15
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Expansion	TRPH-222	Estimated to be \<121 subjects across multiple centers
Escalation	TRPH-222	Estimated to be \<31 subjects across multiple centers

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	21 days	To determine the MTD of TRPH-222

Secondary Outcome Measures

Name	Time	Method
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	Safety
TRPH-222 anti-drug antibodies (ADA)	Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60	Assess the incidence of subjects who develop ADA to the ADC with TRPH-222 monotherapy
Tumor Activity	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
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	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)

Trial Locations

Locations (7)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States

Banner MD Anderson; 🇺🇸 Gilbert, Arizona, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada

Sarah Cannon Research Institute at Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada