Nasopharyngeal Carcinoma (NPC)Phase 2NCT07902713
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Becotatug Vedotin (MRG003), Gemcitabine (1000 mg/m2) and Camrelizumab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a single-center, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of becotatug vedotin combined with gemcitabine and a PD-1 inhibitor as second-line or later treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have experienced treatment failure… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Becotatug Vedotin (MRG003), Gemcitabine (1000 mg/m2) and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Dec 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study and provision of written informed consent.
- Male or nonpregnant female patients aged 18-70 years.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) with treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy. The two treatment modalities may have been administered concurrently as part of a first-line regimen or sequentially. Patients must be considered unsuitable for curative local salvage treatment, including surgery, re-irradiation, or other definitive local therapies.
- At least one measurable lesion according to RECIST version 1.1. Previously irradiated lesions cannot be selected as target lesions unless unequivocal progression has been documented at least 3 months after the last radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate hematologic function, defined as:
- Hemoglobin ≥90 g/L;
- White blood cell count ≥4.0 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L.
- Adequate hepatic function, defined as:
- Total bilirubin <2.0 × upper limit of normal (ULN);
- AST and ALT ≤2.5 × ULN in patients without liver metastases, or ≤3.0 × ULN in patients with liver metastases;
- Alkaline phosphatase ≤1.5 × ULN, or ≤2.0 × ULN in patients with liver metastases;
- Serum albumin ≥30 g/L.
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤1.5 × ULN. Patients receiving anticoagulant therapy are eligible if their anticoagulation parameters are within the therapeutic range and are closely monitored by the investigator.
- Adequate renal function, defined as serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min calculated using the adjusted Cockcroft-Gault formula if serum creatinine exceeds 1.5 × ULN.
- Women of childbearing potential and male patients of reproductive potential must agree to use adequate contraception throughout study treatment and for 180 days after the last dose of study treatment.
Who cannot join
- Histologically confirmed keratinizing squamous cell carcinoma (WHO type I).
- Grade ≥2 peripheral neuropathy according to CTCAE version 5.0.
- Anticipated requirement for surgery or any other systemic or local anticancer therapy during the study, including palliative treatment, except for palliative treatment directed at non-target lesions.
- Receipt of any of the following treatments before the first dose of study treatment:
- Systemic chemotherapy within 3 weeks;
- Small-molecule targeted therapy within 2 weeks or 5 half-lives, whichever is longer;
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- Anticancer biological therapy, macromolecular targeted therapy, or immunotherapy within 4 weeks;
- Major surgery within 4 weeks, except for minor surgery performed within 2 weeks with complete recovery;
- Radiotherapy within 14 days, or radiotherapy to the central nervous system within 28 days.
- Known active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if clinically stable, without progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache, and without evidence of lesion enlargement on MRI during the preceding 4 weeks or a requirement for corticosteroids during the 14 days before the first dose of study treatment.
- Residual toxicities from previous anticancer treatment, including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, or clinically significant laboratory abnormalities greater than grade 1 according to CTCAE version 5.0, except for alopecia, fatigue, and grade 2 hypothyroidism.
- Uncontrolled or poorly controlled cardiovascular disease, including any of the following:
- Grade ≥2 congestive heart failure within 6 months before enrollment;
- Myocardial infarction or unstable angina;
- History of ventricular tachycardia or torsades de pointes;
- Clinically significant arrhythmias requiring treatment;
- QTcF >450 ms in males or >470 ms in females;
- Complete left bundle branch block or third-degree atrioventricular block.
- Pulmonary embolism or deep vein thrombosis within 3 months before the first dose of study treatment, except for thrombosis associated with an implanted venous port or peripherally inserted central catheter (PICC).
- History of another malignancy unless the patient has received potentially curative treatment and remained recurrence-free for at least 5 years. Exceptions include adequately treated basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, carcinoma in situ, and papillary thyroid carcinoma.
- Any severe or uncontrolled systemic disease, including poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) or poorly controlled diabetes mellitus (HbA1c >8%).
- Active bleeding, history of a bleeding or coagulation disorder, or current treatment with coumarin anticoagulants.
- Known hypersensitivity to any component or excipient of becotatug vedotin, including citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80; or a history of grade ≥3 hypersensitivity reactions to other anti-EGFR agents or monoclonal antibodies.
- Active hepatitis B or hepatitis C infection, defined as:
- Hepatitis B surface antigen (HBsAg) positivity with HBV DNA ≥500 IU/mL;
- Hepatitis C antibody positivity with detectable HCV RNA above the lower limit of detection.
- Patients with other severe liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis, sclerosing cholangitis, alcoholic liver disease, or nonalcoholic steatohepatitis (NASH), will also be excluded.
- Severe uncontrolled infection, known HIV infection, or acquired immunodeficiency syndrome (AIDS); active autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism controlled with replacement therapy, or skin disorders not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); or a history of allogeneic tissue or organ transplantation, stem cell transplantation, or bone marrow transplantation.
- Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic antimicrobial treatment, unless adequately treated and resolved before the first dose of study treatment.
- Receipt of a live-virus vaccine within 30 days before the first dose of study treatment.
- History of or concurrent interstitial pneumonitis, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, or symptomatic bronchospasm.
- Receipt of immunologically based treatment for any reason, including chronic systemic corticosteroid therapy equivalent to >10 mg/day of prednisone within 7 days before the first dose of study treatment or during study participation. Inhaled or topical corticosteroids, systemic corticosteroids equivalent to ≤10 mg/day of prednisone, and short-term corticosteroid use at higher doses for specific indications (such as premedication before contrast administration) are permitted.
- Uncontrolled pleural, abdominal, pelvic, or pericardial effusion requiring drainage at least once per month.
- Positive pregnancy test, current breastfeeding, or unwillingness to use adequate contraception during study treatment and for 180 days after the last dose of study treatment.
- Any other disease, clinically significant laboratory abnormality, serious medical or psychiatric condition, or substance abuse (including alcohol abuse) that, in the investigator's judgment, may compromise patient safety, study integrity, study participation, or interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ziying Wang, +8617819566556, wangziying6556@163.com
Yijun Hua, MD
About this study
Official title: A Single-Arm Phase II Clinical Trial of Becotatug Vedotin Combined With Gemcitabine and a PD-1 Inhibitor as Second-Line or Later Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior Platinum-Based Chemotherapy or PD-(L)1 Inhibitor Therapy
This is a single-center, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of becotatug vedotin combined with gemcitabine and a PD-1 inhibitor as second-line or later treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy.
Patients with recurrent or metastatic NPC who are unsuitable for curative local treatment and meet the eligibility criteria will receive becotatug vedotin, gemcitabine, and a PD-1 inhibitor every 3 weeks for 4-6 cycles, followed by PD-1 inhibitor maintenance therapy until disease progression or unacceptable toxicity.
Read more
Approximately 30 patients will be enrolled. The primary objective is to evaluate the objective response rate (ORR) according to RECIST version 1.1. Secondary objectives include evaluating disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and treatment safety.
This study aims to explore a potential treatment option for patients with recurrent or metastatic NPC who have limited therapeutic options after failure of previous systemic therapy.
Read the detailed description
Study Design
This is a prospective, single-center, single-arm, phase II clinical trial conducted at Sun Yat-sen University Cancer Center.
The study plans to enroll approximately 30 patients with histologically or cytologically confirmed recurrent or metastatic NPC who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy and are unsuitable for curative local treatment. Eligible patients must have at least one measurable lesion according to RECIST version 1.1 and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Treatment Plan
All eligible patients will receive the following combination treatment in 21-day cycles:
- Becotatug vedotin: 2.0 mg/kg intravenously on Day 1.
- Gemcitabine: 1,000 mg/m² intravenously on Days 1 and 8.
- PD-1 inhibitor (camrelizumab): 200 mg intravenously on Day 1.
Combination treatment will be administered for 4-6 cycles, depending on treatment response, tolerability, and investigator assessment.
Following combination treatment, patients will receive maintenance therapy with a PD-1 inhibitor (camrelizumab, 200 mg intravenously every 3 weeks) until disease progression or unacceptable toxicity.
Dose modifications, treatment delays, and treatment discontinuation will be managed according to the study protocol.
Efficacy and Safety Assessments
The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1.
Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety outcomes, including treatment-related adverse events, grade 3 or higher treatment-related adverse events, serious adverse events, and adverse events leading to dose modifications or treatment discontinuation.
Tumor assessments will be performed at baseline, every 2 treatment cycles during combination therapy, and approximately every 9-12 weeks during maintenance treatment. Safety will be assessed throughout the study using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Exploratory biomarker analyses may be performed using peripheral blood and available tumor tissue samples to investigate potential associations between biological markers, treatment response, and toxicity.
Statistical Considerations
The sample size is based on a Simon two-stage design, assuming a historical ORR of 35% and an expected ORR of 60%, with a one-sided significance level of 0.05 and a statistical power of 80%.
In the first stage, 9 evaluable patients will be enrolled. If 3 or fewer patients achieve an objective response, the study will be terminated early for insufficient efficacy. If at least 4 patients achieve an objective response, an additional 18 evaluable patients will be enrolled in the second stage.
A total of 27 evaluable patients are required. If at least 13 patients achieve an objective response, the treatment regimen will be considered worthy of further investigation. Allowing for approximately 10% of patients being unevaluable, the planned enrollment is 30 patients.
Safety Monitoring
An initial safety run-in will be implemented using staggered enrollment of the first 3 patients. Safety will be reviewed after the first treatment cycle. A subsequent safety review will be conducted after the first 6 patients have completed at least 2 treatment cycles or 42 days of safety observation.
Additional periodic safety reviews will be performed during enrollment. Enrollment may be temporarily suspended if serious or unexpected treatment
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Becotatug Vedotin (MRG003), Gemcitabine (1000 mg/m2), Camrelizumab
- Keywords
- Recurrent Nasopharyngeal Carcinoma, Antibody-Drug Conjugate, Becotatug Vedotin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin (MRG003)Drug
Becotatug vedotin (MRG003), an EGFR-targeting antibody-drug conjugate (ADC), will be administered intravenously at 2.0 mg/kg on Day 1 of each 21-day cycle for 4-6 cycles in combination with gemcitabine and a PD-1 inhibitor. Dose modifications and treatment delays will be permitted according to the study protocol.
Gemcitabine (1000 mg/m2)Drug
Gemcitabine will be administered intravenously at 1,000 mg/m² on Days 1 and 8 of each 21-day cycle for 4-6 cycles, in combination with becotatug vedotin and a PD-1 inhibitor. Dose modifications and treatment delays will be permitted according to the study protocol.
CamrelizumabDrug
Camrelizumab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle for 4-6 cycles in combination with becotatug vedotin and gemcitabine. Following combination treatment, camrelizumab maintenance therapy will continue at 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin + Gemcitabine + PD-1 Inhibitor | Experimental | Participants will receive becotatug vedotin (2.0 mg/kg intravenously on Day 1), gemcitabine (1,000 mg/m² intravenously on Days 1 and 8), and a PD-1 inhibitor (camrelizumab, 200 mg intravenously on Day 1) every 21 days for 4-6 cycles. Following combination treatment, participants will receive maintenance therapy with a PD-1 inhibitor (camrelizumab, 200 mg intravenously every 3 weeks) until disease progression or unacceptable toxicity. Receives: Drug: Becotatug Vedotin (MRG003); Drug: Gemcitabine (1000 mg/m2); Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, from the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first.
Measured: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first (assessed up to approximately 24 months).
Secondary outcomes (6)
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.
Measured: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first (assessed up to approximately 24 months).
Duration of Response (DoR)
Duration of response (DoR) is defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response.
Measured: From the first documented CR or PR until disease progression or death (assessed up to approximately 24 months).
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From the first dose of study treatment until disease progression or death (assessed up to approximately 24 months).
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Measured: From the first dose of study treatment until death from any cause (assessed up to approximately 24 months).
Incidence of Treatment-Related Adverse Events (TRAEs)
The proportion of participants experiencing at least one treatment-related adverse event (TRAE), with severity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: During study treatment and protocol-specified safety follow-up (approximately up to 24 months).
Incidence of Serious Adverse Events (SAEs)
The proportion of participants experiencing at least one serious adverse event (SAE), regardless of its relationship to study treatment.
Measured: During study treatment and protocol-specified safety follow-up (up to approximately 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiJun Hua, Sun Yat-sen University
- Investigators
- Yijun Hua, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902713
- Sponsor's protocol ID
- 2025-FXY-541-NPC
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to patient privacy and confidentiality considerations. Study data will be securely maintained by the research team in accordance with institutional policies and applicable ethical requirements. Aggregate study results may be disseminated through scientific publications and academic presentations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Clinical Trial of Becotatug Vedotin Combined With Gemcitabine and a PD-1 Inhibitor as Second-Line or Later Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior Platinum-Based Chemotherapy or PD-(L)1 Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT07902713
- Acronym / sponsor ID
- 2025-FXY-541-NPC
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Recurrent Nasopharyngeal Carcinoma, Antibody-Drug Conjugate, Becotatug Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Oct 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 is a single-center, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of becotatug vedotin combined with gemcitabine and a PD-1 inhibitor as second-line or later treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy.
Patients with recurrent or metastatic NPC who are unsuitable for curative local treatment and meet the eligibility criteria will receive becotatug vedotin, gemcitabine, and a PD-1 inhibitor every 3 weeks for 4-6 cycles, followed by PD-1 inhibitor maintenance therapy until disease progression or unacceptable toxicity.
Approximately 30 patients will be enrolled. The primary objective is to evaluate the objective response rate (ORR) according to RECIST version 1.1. Secondary objectives include evaluating disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and treatment safety.
This study aims to explore a potential treatment option for patients with recurrent or metastatic NPC who have limited therapeutic options after failure of previous systemic therapy.
Detailed description
Study Design
This is a prospective, single-center, single-arm, phase II clinical trial conducted at Sun Yat-sen University Cancer Center.
The study plans to enroll approximately 30 patients with histologically or cytologically confirmed recurrent or metastatic NPC who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy and are unsuitable for curative local treatment. Eligible patients must have at least one measurable lesion according to RECIST version 1.1 and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Treatment Plan
All eligible patients will receive the following combination treatment in 21-day cycles:
- Becotatug vedotin: 2.0 mg/kg intravenously on Day 1.
- Gemcitabine: 1,000 mg/m² intravenously on Days 1 and 8.
- PD-1 inhibitor (camrelizumab): 200 mg intravenously on Day 1.
Combination treatment will be administered for 4-6 cycles, depending on treatment response, tolerability, and investigator assessment.
Following combination treatment, patients will receive maintenance therapy with a PD-1 inhibitor (camrelizumab, 200 mg intravenously every 3 weeks) until disease progression or unacceptable toxicity.
Dose modifications, treatment delays, and treatment discontinuation will be managed according to the study protocol.
Efficacy and Safety Assessments
The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1.
Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety outcomes, including treatment-related adverse events, grade 3 or higher treatment-related adverse events, serious adverse events, and adverse events leading to dose modifications or treatment discontinuation.
Tumor assessments will be performed at baseline, every 2 treatment cycles during combination therapy, and approximately every 9-12 weeks during maintenance treatment. Safety will be assessed throughout the study using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Exploratory biomarker analyses may be performed using peripheral blood and available tumor tissue samples to investigate potential associations between biological markers, treatment response, and toxicity.
Statistical Considerations
The sample size is based on a Simon two-stage design, assuming a historical ORR of 35% and an expected ORR of 60%, with a one-sided significance level of 0.05 and a statistical power of 80%.
In the first stage, 9 evaluable patients will be enrolled. If 3 or fewer patients achieve an objective response, the study will be terminated early for insufficient efficacy. If at least 4 patients achieve an objective response, an additional 18 evaluable patients will be enrolled in the second stage.
A total of 27 evaluable patients are required. If at least 13 patients achieve an objective response, the treatment regimen will be considered worthy of further investigation. Allowing for approximately 10% of patients being unevaluable, the planned enrollment is 30 patients.
Safety Monitoring
An initial safety run-in will be implemented using staggered enrollment of the first 3 patients. Safety will be reviewed after the first treatment cycle. A subsequent safety review will be conducted after the first 6 patients have completed at least 2 treatment cycles or 42 days of safety observation.
Additional periodic safety reviews will be performed during enrollment. Enrollment may be temporarily suspended if serious or unexpected treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin + Gemcitabine + PD-1 Inhibitor | Experimental | Drug: Becotatug Vedotin (MRG003), Drug: Gemcitabine (1000 mg/m2), Drug: CamrelizumabParticipants will receive becotatug vedotin (2.0 mg/kg intravenously on Day 1), gemcitabine (1,000 mg/m² intravenously on Days 1 and 8), and a PD-1 inhibitor (camrelizumab, 200 mg intravenously on Day 1) every 21 days for 4-6 cycles. Following combination treatment, participants will receive maintenance therapy with a PD-1 inhibitor (camrelizumab, 200 mg intravenously every 3 weeks) until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntary participation in the study and provision of written informed consent.
- Male or nonpregnant female patients aged 18-70 years.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) with treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy. The two treatment modalities may have been administered concurrently as part of a first-line regimen or sequentially. Patients must be considered unsuitable for curative local salvage treatment, including surgery, re-irradiation, or other definitive local therapies.
- At least one measurable lesion according to RECIST version 1.1. Previously irradiated lesions cannot be selected as target lesions unless unequivocal progression has been documented at least 3 months after the last radiotherapy.
Key exclusion criteria (35 listed)
- Histologically confirmed keratinizing squamous cell carcinoma (WHO type I).
- Grade ≥2 peripheral neuropathy according to CTCAE version 5.0.
- Anticipated requirement for surgery or any other systemic or local anticancer therapy during the study, including palliative treatment, except for palliative treatment directed at non-target lesions.
- Receipt of any of the following treatments before the first dose of study treatment:
- Known active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if clinically stable, without progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache, and without evidence of lesion enlargement on MRI during the preceding 4 weeks or a requirement for corticosteroids during the 14 days before the first dose of study treatment.
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 (MRG003)Becotatug vedotin (MRG003), an EGFR-targeting antibody-drug conjugate (ADC), will be administered intravenously at 2.0 mg/kg on Day 1 of each 21-day cycle for 4-6 cycles in combination with gemcitabine and a PD-1 inhibitor. Dose modifications and treatment delays will be permitted according to the study protocol. | Drug | Becotatug Vedotin + Gemcitabine + PD-1 Inhibitor |
| Gemcitabine (1000 mg/m2)Gemcitabine will be administered intravenously at 1,000 mg/m² on Days 1 and 8 of each 21-day cycle for 4-6 cycles, in combination with becotatug vedotin and a PD-1 inhibitor. Dose modifications and treatment delays will be permitted according to the study protocol. | Drug | Becotatug Vedotin + Gemcitabine + PD-1 Inhibitor |
| CamrelizumabCamrelizumab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle for 4-6 cycles in combination with becotatug vedotin and gemcitabine. Following combination treatment, camrelizumab maintenance therapy will continue at 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. | Drug | Becotatug Vedotin + Gemcitabine + PD-1 Inhibitor |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first (assessed up to approximately 24 months).
Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, from the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first.
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first (assessed up to approximately 24 months).
Duration of Response (DoR)
Time frame: From the first documented CR or PR until disease progression or death (assessed up to approximately 24 months).
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death (assessed up to approximately 24 months).
Overall Survival (OS)
Time frame: From the first dose of study treatment until death from any cause (assessed up to approximately 24 months).
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: During study treatment and protocol-specified safety follow-up (approximately up to 24 months).
Incidence of Serious Adverse Events (SAEs)
Time frame: During study treatment and protocol-specified safety follow-up (up to approximately 24 months).
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to patient privacy and confidentiality considerations. Study data will be securely maintained by the research team in accordance with institutional policies and applicable ethical requirements. Aggregate study results may be disseminated through scientific publications and academic presentations.
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Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 2
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
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.
Yijun Hua, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin (MRG003), Gemcitabine (1000 mg/m2) and Camrelizumab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
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 18 inclusion and 35 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ziying Wang (+8617819566556, wangziying6556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the first dose of study treatment until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first (assessed up to approximately 24 months).). 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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.