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Clinical Trials/NCT07381699
NCT07381699
Not yet recruiting
Phase 2

Becotatug Vedotin Plus Pucotenlimab as First-line Therapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial

West China Hospital0 sites30 target enrollmentStarted: February 1, 2026Last updated:
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InterventionsBecotatug Vedotin and Pucotenlimab

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Progression Free Survival (PFS)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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.
  • •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.

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.
  • •Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).
  • •Known history of testing positive for human immunodeficiency virus (HIV).

Arms & Interventions

MRG003 + PD-1 inhibitor

Experimental

Subjects receive becotatug vedotin plus pucotenlimab

Intervention: Becotatug Vedotin and Pucotenlimab (Drug)

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: Up to approximately 2 years.

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

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lei Liu

Director of head and neck oncology Department

West China Hospital

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