Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07730515
PHASE1/PHASE2

Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

Sponsor: Evopoint Biosciences Inc.

View on ClinicalTrials.gov

Summary

In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients.

Official title: A Phase Ib/II Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2025-08-15

Completion Date

2028-09-30

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

XNW5004 combined with CHOP (incremental)

The XNW5004 protocol has preset four dosage groups: 400mg, 800mg, 1200mg and 1600mg, administered twice daily (BID). The CHOP regimen is administered at a fixed dose, for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

DRUG

XNW5004 combined with CHOEP (incremental)

It is expected to conduct dose escalation studies for XNW5004 in combination with CHOEP using 1-3 dose groups. The CHOEP regimen will be administered at a fixed dose for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

DRUG

XNW5004 combined with CHOP (extended)

Those who received the combination treatment of XNW5004 and CHOP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

DRUG

XNW5004 combined with CHOEP (extended)

Those who received the combination treatment of XNW5004 and CHOEP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

Locations (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China