ClinicalTrials.gg
RecruitingNCT07781358Updated Aug 24, 2026

Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.

A Phase 2 interventional study of Becotatug Vedotin and PD-1 / PD-L1 monoclonal antibody in Nasopharyngeal Carcinoma (NPC), sponsored by Hongmeng Yu. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Hongmeng Yu · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Planned enrollment
9th of 10
25 · median 43
Started
2026
with 7 others
Phase 2
7 of 10
5 open now
Registered
9th of 10
by date
Lead sponsor
1 of 10
Hongmeng Yu

Among the 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma, this one is the 9th largest by planned enrollment, is one of 8 that started in 2026, is one of 7 in phase 2, and was the 9th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Phase 2this study7 · 5 open
Phase 32 · 2 open
Phase 11 · 1 open

By the year they started

First in 2023; this study’s year is marked. 8 started in 2026.

Tested beside becotatug vedotin

Size and results

Median enrollment 43 across the 10 interventional studies. None of them has completed or been terminated yet.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies testing becotatug vedotin in Nasopharyngeal Carcinoma, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Nasopharyngeal Carcinoma (NPC)

Keywords

  • nasopharyngeal carcinoma
  • ADC
  • Becotatug Vedotin
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Written obtained prior to any trial-related procedures.
  • ≥ 18 years of age.
  • or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant . 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 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment.
  • performance status 0-1.
  • ≥ 3 months.
  • Adequate organ function for drugs and surgery
  • For female patients of , 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 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 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).

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of any 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 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 disease requiring systemic treatment (e.g., disease-modifying drugs, , or ) 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.
  • 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 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 (HIV) infection (i.e., HIV 1/2 antibody positive).
  • Untreated active (defined as HBsAg positive with detectable HBV-DNA copy number exceeding the 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 infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).

  • Receipt of 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.
Terms in these criteria, in plain language(20)

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.

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

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.

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.

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.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    becotatug vedotin + PD-1 inhibitor

    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.

    Drug: Becotatug Vedotin · Drug: PD-1 / PD-L1 monoclonal antibody

Interventions

  • Becotatug vedotin 2.0 mg/kg, intravenous infusion, once every 3 weeks

  • DrugPD-1 / PD-L1 monoclonal antibody

    Drug page: Immune checkpoint inhibitors

    PD-1 immune checkpoint inhibitor, administered according to the prescribing information of the investigator's chosen agent.

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 12 weeks

  2. 1-year and 2-year progression-free survival (PFS) rates

    Time frame: end of 1st year, end of 2nd year

Secondary outcomes

  1. 1-year and 2-year overall survival (OS) rates

    Time frame: end of 1st year, end of 2nd year

  2. pCR rate, R0 resection rate, and resectability rate

    Time frame: week 16 after enrollment day

  3. 1-year and 2-year locoregional recurrence-free survival (LRFS) rates

    Time frame: end of 1st year, end of 2nd year

  4. 1-year and 2-year distant metastasis-free survival (DMFS) rates

    Time frame: end of 1st year, end of 2nd year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

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 12 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.

Registered
Aug 11, 2026
First posted
Aug 24, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2029
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781358
Lead sponsor
Hongmeng Yu
Responsible party
Hongmeng Yu (Chief Physician, Eye & ENT Hospital of Fudan University) — Sponsor-investigator
First posted
Aug 24, 2026
Start date
Aug 1, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Aug 24, 2026

Study contacts

Li Yan, MD
Contact
yanl13@fudan.edu.cn
+86 021-64377134
Xiaole Song, MD
Contact
jxfxsxl@163.com
Li Yan
study director · Eye&ENT Hospital
Hongmeng Yu
principal investigator · Eye&ENT Hospital
Xiaole Song
study director · Eye&ENT Hospital
Quan Liu
study director · Eye&ENT Hospital
Kai Xue
study director · Eye&ENT Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Becotatug vedotin · Immune checkpoint inhibitors

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