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