A Phase 2 interventional study of Becotatug Vedotin (MRG003) and Gemcitabine (1000 mg/m2) in Nasopharyngeal Carcinoma (NPC), sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
Among 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma — 8 open to participants now, 10 under way, 2 of them phase 3. becotatug vedotin · Nasopharyngeal Carcinoma.
Among the 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma, this one is the 7th largest by planned enrollment, is one of 8 that started in 2026, is one of 7 in phase 2, and was the 10th registered.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →8 of the 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma are open now, in 1 country. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2023; this study’s year is marked. 8 started in 2026.
Median enrollment 43 across the 10 interventional studies. None of them has completed or been terminated yet.
2 of 10 have an industry lead sponsor. The 7 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University: 80 open now, 107 under way, 43 of them phase 3. Of 28 finished, 1 (4%) have results posted.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, this one is the 147th largest by planned enrollment of the 161 interventional ones, is one of 14 that started in 2026, is one of 72 in phase 2, reaches primary completion later than 92 of the 106 other live ones, and was the 186th registered.
Sun Yat-sen University’s Nasopharyngeal Carcinoma studies by the year they started, since 1998.
3 of the studies testing becotatug vedotin in Nasopharyngeal Carcinoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07584499Sun Yat-sen UniversityPhase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors | 2027-05-30 |
| NCT07781358Hongmeng YuBecotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma. | 2027-08-01 |
| NCT07267338Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPembrolizumab + MRGOO3 as Neoadjuvant in NPC | 2027-10 |
Among the 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma, from their registry updates:
Among Sun Yat-sen University’s 186 in Nasopharyngeal Carcinoma:
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.
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:
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate hematologic function, defined as:
Adequate hepatic function, defined as:
Exclusion Criteria:
Receipt of any of the following treatments before the first dose of study treatment:
Uncontrolled or poorly controlled cardiovascular disease, including any of the following:
Active or infection, defined as:
Patients with other severe liver diseases, including chronic liver disease, primary biliary cirrhosis, sclerosing cholangitis, alcoholic liver disease, or nonalcoholic steatohepatitis (NASH), will also be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Becotatug Vedotin (MRG003) · Drug: Gemcitabine (1000 mg/m2) · Drug: Camrelizumab
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 page: Gemcitabine
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.
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.
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.
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).
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.
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)
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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: During study treatment and protocol-specified safety follow-up (up to approximately 24 months).
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 128 non-industry phase 2 interventional studies under Nasopharyngeal Carcinoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 74. This study's planned 25 months is below that.
Counting every sponsor, half of 143 studies reached it within 43 months; a quarter within 28 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Becotatug vedotin