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

NCT07781358 | Recruiting Phase 2

• 1 other identifier: 2026040
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma; ADC; Becotatug Vedotin

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  12 weeks

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

  end of 1st year, end of 2nd year

Secondary Outcomes (4)

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

  end of 1st year, end of 2nd year

• pCR rate, R0 resection rate, and resectability rate

  week 16 after enrollment day

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

  end of 1st year, end of 2nd year

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

  end of 1st year, end of 2nd year

Study Arms (1)

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.

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

Interventions

Becotatug Vedotin DRUG

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

becotatug vedotin + PD-1 inhibitor

PD-1 / PD-L1 monoclonal antibody DRUG

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

becotatug vedotin + PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hongmeng Yu: lead

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Li Yan

  Eye&ENT Hospital

  STUDY DIRECTOR

• Hongmeng Yu

  Eye&ENT Hospital

  PRINCIPAL INVESTIGATOR

• Xiaole Song

  Eye&ENT Hospital

  STUDY DIRECTOR

• Quan Liu

  Eye&ENT Hospital

  STUDY DIRECTOR

• Kai Xue

  Eye&ENT Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Yan, MD

CONTACT

+86 021-64377134; yanl13@fudan.edu.cn

Xiaole Song, MD

CONTACT

jxfxsxl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)