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NOT YET RECRUITING
NCT07035379
PHASE1/PHASE2

A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone(T-CHP) in Previously Untreated Patients With CD20-positive DLBCL

Sponsor: Zhejiang Teruisi Pharmaceutical Inc.

View on ClinicalTrials.gov

Summary

This trial is a multicenter, open-label, single-arm, dose-escalation and dose-expansion clinical trial. The dose was increased according to the "3 + 3" rule. Patients with previously untreated patients with CD20-positive DLBCL were selected to evaluate the safety, tolerance (DLT, MTD), pharmacokinetics, and anti-tumor activity of TRS005 in combination with standard doses of cyclophosphamide, doxorubicin, and prednisone(T-CHP) by intravenous drip every 3 weeks.

Official title: A Phase I/II Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone(T-CHP) in Previously Untreated Patients With CD20-positive DLBCL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-09-01

Completion Date

2028-09-01

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DRUG

TRS005

TRS005 will be administered at a starting dose of 0.8mg/kg IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles (up to 8).

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m\^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

DRUG

Doxorubicin

Doxorubicin will be administered at 50 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

DRUG

Prednisolone

Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Locations (1)

Chinese Academy of Medical Sciences, Cancer Hospital

Beijing, Beijing Municipality, China