NCT07331428

MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC

Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.

Conditions

• Nasopharyngeal Carcinoma
• Local Recurrence

Interventions

Type	Name	Description
DRUG	MRG003	MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles
DRUG	Tislelizumab	Tislelizumab 200 mg (D1) will be administered every three weeks for 6 cycles. Upon achieving an objective response, maintenance therapy will continue for up to one year or until disease progression is observed.
DRUG	Capecitabine	After achieving an objective response (ORR) with the combination of MRG003 and Tislelizumab, maintenance therapy will consist of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-01-09
• Last updated: 2026-01-09