Not Yet RecruitingPhase 2

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

30 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Progression Free Survival (PFS)

Timeframe: Up to approximately 2 years.

Trial details

NCT IDNCT07381699

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Lei Liu

+86 189 8060 6231 liuleihx@gmail.com

View on ClinicalTrials.gov More Nasopharyngeal Cancinoma (NPC) trials