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

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Nasopharyngeal Carcinoma; Local Recurrence

Treatments: Drug: Capecitabine; Drug: Tislelizumab; Drug: MRG003

Study type: Interventional

Funder types: Other

Identifiers

NCT07331428

2025-12-19

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

**Inclusion Criteria:**

1. Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis.
2. Age 18-70 years.
3. Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.
4. ECOG performance status score of 0-1.
5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.
6. No contraindications to immunotherapy or chemotherapy.
7. Adequate organ function.

Exclusion criteria

**Exclusion Criteria:**

1. Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.
2. Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0).
3. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies/ml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay).
4. Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MRG003

Experimental group

Description:

The treatment regimen comprises an induction phase with MRG003 at 2.0 mg/kg (administered on Day 1) in combination with Tislelizumab 200 mg (also on Day 1), delivered every three weeks for a total of six cycles. Upon achieving an objective response (ORR), patients will proceed to maintenance therapy, which consists 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.

Treatment:

Drug: MRG003

Drug: Tislelizumab

Drug: Capecitabine