MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial

NCT07381699 | Not Yet Recruiting Phase 2

• 1 other identifier: WCH-2026-NPC-PII-MRG003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to compare the efficacy and safety of Becotatug Vedotin (MRG003) combined with Pucotenlimab as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Nasopharyngeal Cancinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Defined as the period from treatment initiation until disease progression or death from any cause, whichever occurs first.

  Up to approximately 2 years.

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to approximately 2 years.

• The proportion of patients who achieved disease control

  Up to approximately 2 years.

• Duration of Response (DoR)

  Up to approximately 2 years.

• Overall Survival (OS)

  Up to approximately 2 years.

• Incidence of adverse events

  Up to approximately 2 years.

Study Arms (1)

MRG003 + PD-1 inhibitor

EXPERIMENTAL

Subjects receive becotatug vedotin plus pucotenlimab

Drug: Becotatug Vedotin and Pucotenlimab

Interventions

Becotatug Vedotin and Pucotenlimab DRUG

Becotatug Vedotin (2.0mg/kg, ivgtt, every 3 weeks, D1) combined with Pucotenlimab (200mg, ivgtt, every 3 weeks, D1) is administered until disease progression (PD), unacceptable toxicity, or death.

MRG003 + PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC).
• Metastatic NPC (Stage IVB, AJCC 8th) or locally recurrent NPC unfit for curative local therapy (e.g., surgery, TACE, radiotherapy).
• Must be treatment-naive for recurrent or metastatic NPC.
• Must have ≥ 1 measurable lesions as defined per RECIST v1.1.
• Adequate organ function.
• For women of childbearing potential: negative pregnancy test within 7 days prior to treatment initiation. All participants of childbearing potential must agree to use effective contraception during the study and for 1 year after treatment discontinuation.
• Willing and able to provide written informed consent and comply with study procedures and follow-up visits.

You may not qualify if:

• Peripheral neuropathy of Grade 2 or higher.
• Anticipated need for any other local or systemic anti-tumor therapy during the study period.
• Diagnosed and/or treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma.
• Active central nervous system (CNS) metastases or carcinomatous meningitis.
• Laboratory values within 7 days prior to enrollment falling outside specified eligibility ranges (e.g., Child-Pugh C; creatinine clearance \<30 mL/min; serum sodium \<135 mmol/L; serum potassium \<3.5 mmol/L).
• Severe or uncontrolled cardiovascular disease.
• History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm.
• Active infection requiring systemic therapy.
• Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).
• Known history of testing positive for human immunodeficiency virus (HIV).
• Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation.
• Known active hepatitis B or C infection, or other severe liver disease.
• Live vaccine within 30 days prior to the first dose.
• Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism).
• Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.

Sponsors & Collaborators

• West China Hospital: lead

Central Study Contacts

Lei Liu

CONTACT

+86 189 8060 6231; liuleihx@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of head and neck oncology Department

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-01