Nasopharyngeal Carcinoma (NPC)Phase 2NCT07781358
Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.
A Phase 2 study testing Becotatug Vedotin and PD-1 / PD-L1 monoclonal antibody in people with Nasopharyngeal Carcinoma (NPC), run by Hongmeng Yu at 1 site in China.
Trial summary
This study plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Becotatug Vedotin and PD-1 / PD-L1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any trial-related procedures.
- ≥ 18 years of age.
- Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant metastases. Including patients with local recurrence at T2 stage and/or retropharyngeal lymph node metastasis adjacent to the internal carotid artery.
- At least one lesion at baseline meeting RECIST 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment.
- ECOG performance status 0-1.
- Life expectancy ≥ 3 months.
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- Adequate organ function for drugs and surgery
- For female patients of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1 Day 1) and the result must be negative. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
- If there is a risk of conception, all subjects (male or female) must use contraceptive methods with a failure rate of < 1% per year during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy, if applicable).
Who cannot join
- Diagnosis of any malignancy other than nasopharyngeal carcinoma within 5 years prior to first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically resected).
- Prior treatment with an ADC drug containing MMAE as the payload.
- Known active bleeding signs of the lesion under endoscopy.
- Currently participating in an interventional clinical study, or having received another investigational drug or used an investigational device within 4 weeks prior to first dose.
- Systemic treatment with traditional Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding topical use for pleural effusion control) within 2 weeks prior to first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
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- Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to first dose.
- Note: Physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent) are permitted.
- History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Failure to fully recover from toxicity and/or complications caused by any prior intervention (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) before starting treatment.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number exceeding the upper limit of normal of the central laboratory).
- Note: Hepatitis B subjects meeting the following criteria may also be enrolled:
- HBV viral load < 1000 copies/mL (200 IU/mL) prior to first dose; subjects should receive anti-HBV therapy throughout the study chemotherapy period to prevent viral reactivation.
- For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.
- Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- Receipt of live vaccine within 30 days prior to first dose (Cycle 1, Day 1). Note: Injectable inactivated influenza vaccines for seasonal flu are allowed within 30 days prior to first dose; however, intranasally administered live attenuated influenza vaccines are not permitted.
- Pregnant or lactating women. Presence of any severe or uncontrolled systemic disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaole Song, MD contact
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Li Yan, MD, +86 021-64377134, yanl13@fudan.edu.cn
About this study
Official title: An Exploratory, Single-arm, Phase II Study of Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.
This study plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Following treatment, imaging assessment and surgical evaluation will be performed. Subjects deemed operable will undergo endoscopic nasal surgery, after which the MDT (multidisciplinary team) will discuss and determine a maintenance treatment plan. For subjects who are not eligible for surgery, the MDT will decide on either maintenance therapy or a switch to an alternative treatment regimen.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Becotatug Vedotin, PD-1 / PD-L1 monoclonal antibody
- Keywords
- nasopharyngeal carcinoma, ADC, 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 VedotinDrug
Becotatug vedotin 2.0 mg/kg, intravenous infusion, once every 3 weeks
PD-1 / PD-L1 monoclonal antibodyDrug
PD-1 immune checkpoint inhibitor, administered according to the prescribing information of the investigator's chosen agent.
| Study group | Role | What they receive |
|---|---|---|
| becotatug vedotin + PD-1 inhibitor | Experimental | three cycles of becotatug vedotin combined with a PD-1 inhibitor. Subjects deemed operable will undergo endoscopic nasal surgery and a maintenance treatment plan decided by MDT group. Receives: Drug: Becotatug Vedotin; Drug: PD-1 / PD-L1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 12 weeks
1-year and 2-year progression-free survival (PFS) rates
Measured: end of 1st year, end of 2nd year
Secondary outcomes (4)
1-year and 2-year overall survival (OS) rates
Measured: end of 1st year, end of 2nd year
pCR rate, R0 resection rate, and resectability rate
Measured: week 16 after enrollment day
1-year and 2-year locoregional recurrence-free survival (LRFS) rates
Measured: end of 1st year, end of 2nd year
1-year and 2-year distant metastasis-free survival (DMFS) rates
Measured: end of 1st year, end of 2nd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 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.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongmeng Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongmeng Yu, Eye & ENT Hospital of Fudan University
- Investigators
- Li Yan, Study director, Eye&ENT HospitalHongmeng Yu, Principal investigator, Eye&ENT HospitalXiaole Song, Study director, Eye&ENT HospitalQuan Liu, Study director, Eye&ENT HospitalKai Xue, Study director, Eye&ENT Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781358
- Sponsor's protocol ID
- 2026040
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-arm, Phase II Study of Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.
- ClinicalTrials.gov ID
- NCT07781358
- Acronym / sponsor ID
- 2026040
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, ADC, Becotatug Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hongmeng YuUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 24 Aug 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 plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Following treatment, imaging assessment and surgical evaluation will be performed. Subjects deemed operable will undergo endoscopic nasal surgery, after which the MDT (multidisciplinary team) will discuss and determine a maintenance treatment plan. For subjects who are not eligible for surgery, the MDT will decide on either maintenance therapy or a switch to an alternative treatment regimen.
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 + PD-1 inhibitor | Experimental | Drug: Becotatug Vedotin, Drug: PD-1 / PD-L1 monoclonal antibodythree cycles of becotatug vedotin combined with a PD-1 inhibitor. Subjects deemed operable will undergo endoscopic nasal surgery and a maintenance treatment plan decided by MDT group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained prior to any trial-related procedures.
- ≥ 18 years of age.
- Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant metastases. Including patients with local recurrence at T2 stage and/or retropharyngeal lymph node metastasis adjacent to the internal carotid artery.
- At least one lesion at baseline meeting RECIST 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment.
- ECOG performance status 0-1.
Key exclusion criteria (18 listed)
- Diagnosis of any malignancy other than nasopharyngeal carcinoma within 5 years prior to first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically resected).
- Prior treatment with an ADC drug containing MMAE as the payload.
- Known active bleeding signs of the lesion under endoscopy.
- Currently participating in an interventional clinical study, or having received another investigational drug or used an investigational device within 4 weeks prior to first dose.
- Systemic treatment with traditional Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin; excluding topical use for pleural effusion control) within 2 weeks prior to first dose.
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 VedotinBecotatug vedotin 2.0 mg/kg, intravenous infusion, once every 3 weeks | Drug | becotatug vedotin + PD-1 inhibitor |
| PD-1 / PD-L1 monoclonal antibodyPD-1 immune checkpoint inhibitor, administered according to the prescribing information of the investigator's chosen agent. | Drug | becotatug vedotin + PD-1 inhibitor |
Primary outcome
Objective response rate (ORR)
Time frame: 12 weeks
1-year and 2-year progression-free survival (PFS) rates
Time frame: end of 1st year, end of 2nd year
4 secondary outcomes
1-year and 2-year overall survival (OS) rates
Time frame: end of 1st year, end of 2nd year
pCR rate, R0 resection rate, and resectability rate
Time frame: week 16 after enrollment day
1-year and 2-year locoregional recurrence-free survival (LRFS) rates
Time frame: end of 1st year, end of 2nd year
1-year and 2-year distant metastasis-free survival (DMFS) rates
Time frame: end of 1st year, end of 2nd year
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Xiaole Song, MD contact
Li Yan study director
Eye&ENT Hospital
Hongmeng Yu principal investigator
Eye&ENT Hospital
Xiaole Song study director
Eye&ENT Hospital
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 and PD-1 / PD-L1 monoclonal antibody in people with Nasopharyngeal Carcinoma (NPC), run by Hongmeng Yu 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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 24 Aug 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 Li Yan, MD (+86 021-64377134, yanl13@fudan.edu.cn), 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: 12 weeks). The study lists 2 primary outcomes in all. 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 24 Aug 2026.