NCT03682796

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Triphase Research and Development III Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Lymphoma, Mantle-Cell
• Lymphoma, Marginal Zone
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	TRPH-222	administered by IV, 21-day Cycle

Timeline

• Start date: 2018-10-15
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2018-09-25
• Last updated: 2022-05-19

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study