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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Plus Pucotenlimab as First-line Therapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07381699
- Acronym / sponsor ID
- WCH-2026-NPC-PII-MRG003
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- Nasopharyngeal Cancinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRG003 + PD-1 inhibitor | Experimental | Drug: Becotatug Vedotin and PucotenlimabSubjects receive becotatug vedotin plus pucotenlimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug Vedotin and PucotenlimabBecotatug 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. | Drug | MRG003 + PD-1 inhibitor |
Primary outcome
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.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years.
The proportion of patients who achieved disease control
Time frame: Up to approximately 2 years.
Duration of Response (DoR)
Time frame: Up to approximately 2 years.
Overall Survival (OS)
Time frame: Up to approximately 2 years.
Incidence of adverse events
Time frame: Up to approximately 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin and Pucotenlimab in people with Nasopharyngeal Cancinoma (NPC), run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Liu (+86 189 8060 6231, liuleihx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to approximately 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.