Skip to main content
Clinical Trials/NCT03682796
NCT03682796CompletedPhase 1

Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma

Triphase Research and Development III Corp.7 sites in 2 countries32 target enrollmentStarted: October 15, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
32
Locations
7
Primary Endpoint
Maximum Tolerated Dose (MTD)

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Escalation

Experimental

Estimated to be <31 subjects across multiple centers

Intervention: TRPH-222 (Drug)

Expansion

Experimental

Estimated to be <121 subjects across multiple centers

Intervention: TRPH-222 (Drug)

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD)

Time Frame: 21 days

To determine the MTD of TRPH-222

Secondary Outcomes

  • 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)
  • TRPH-222 anti-drug antibodies (ADA)(Prior to treatment, prior to C3D1 and every 3rd cycle thereafter, EOT60)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

Loading locations...

Similar Trials