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

Condition(s) studied

Investigational drug(s) / intervention(s)

MRG003: MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Objective Response Rate — Day 21 after the completion of six cycles of MRG003 treatment
  The Objective Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) by Day 21 after the completion of six cycles of MRG003 treatment, starting from the date of enrollment.

Trial sites (1)

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