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

February 11, 2026 updated by: Lei Liu, West China Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Life expectancy ≥ 3 months.
  4. Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC).
  5. Metastatic NPC (Stage IVB, AJCC 8th) or locally recurrent NPC unfit for curative local therapy (e.g., surgery, TACE, radiotherapy).
  6. Must be treatment-naive for recurrent or metastatic NPC.
  7. Must have ≥ 1 measurable lesions as defined per RECIST v1.1.
  8. Adequate organ function.
  9. 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.
  10. Willing and able to provide written informed consent and comply with study procedures and follow-up visits.

Exclusion Criteria:

  1. Peripheral neuropathy of Grade 2 or higher.
  2. Anticipated need for any other local or systemic anti-tumor therapy during the study period.
  3. 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.
  4. Active central nervous system (CNS) metastases or carcinomatous meningitis.
  5. 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).
  6. Severe or uncontrolled cardiovascular disease.
  7. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm.
  8. Active infection requiring systemic therapy.
  9. Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).
  10. Known history of testing positive for human immunodeficiency virus (HIV).
  11. Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation.
  12. Known active hepatitis B or C infection, or other severe liver disease.
  13. Live vaccine within 30 days prior to the first dose.
  14. Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism).
  15. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid or immunosuppressive therapy. The following conditions are not exclusionary: mild asthma controlled with intermittent bronchodilators; stable hypothyroidism on hormone replacement; vitiligo; Graves' disease; or Hashimoto's disease.
  16. Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.
  17. Uncontrolled pleural effusion, ascites, or pericardial effusion.
  18. Pregnancy, breastfeeding, or unwillingness to use a highly effective method of contraception during the treatment period and for at least 180 days after the last dose.
  19. Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MRG003 + PD-1 inhibitor
Subjects receive becotatug vedotin plus pucotenlimab
Drug: Becotatug Vedotin and Pucotenlimab
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 2 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years.
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1.
Up to approximately 2 years.
Duration of Response (DoR)
Time Frame: Up to approximately 2 years.
Defined as the time from the first assessment of CR and PR to the first assessment of PD or death caused by any cause according to RECIST 1.1.
Up to approximately 2 years.
Overall Survival (OS)
Time Frame: Up to approximately 2 years.
Defined as the period from treatment initiation until death from any cause.
Up to approximately 2 years.
The proportion of patients who achieved disease control
Time Frame: Up to approximately 2 years.
Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for a certain period of time according to RECIST 1.1.
Up to approximately 2 years.
Incidence of adverse events
Time Frame: Up to approximately 2 years.
NCI-CTCAE 5.0 standard was adopted, and the safety was assessed mainly by ECOG-PS score, physical examination, clinical laboratory tests, electrocardiogram, and adverse event results.
Up to approximately 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCH-2026-NPC-PII-MRG003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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