Nasopharyngeal Cancinoma (NPC)Phase 2NCT07381699
MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial
A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Nasopharyngeal Cancinoma (NPC), run by West China Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Becotatug Vedotin and Pucotenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- 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.
- Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.
- Uncontrolled pleural effusion, ascites, or pericardial effusion.
- 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.
- Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Becotatug Vedotin and Pucotenlimab
- Keywords
- Nasopharyngeal Cancinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin and PucotenlimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MRG003 + PD-1 inhibitor | Experimental | Subjects receive becotatug vedotin plus pucotenlimab Receives: Drug: Becotatug Vedotin and Pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Defined as the period from treatment initiation until disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years.
Secondary outcomes (5)
Objective Response Rate (ORR)
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.
Measured: Up to approximately 2 years.
The proportion of patients who achieved disease control
Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for a certain period of time according to RECIST 1.1.
Measured: Up to approximately 2 years.
Duration of Response (DoR)
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.
Measured: Up to approximately 2 years.
Overall Survival (OS)
Defined as the period from treatment initiation until death from any cause.
Measured: Up to approximately 2 years.
Incidence of adverse events
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.
Measured: Up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381699
- Sponsor's protocol ID
- WCH-2026-NPC-PII-MRG003
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided