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Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

7. maj 2026 opdateret af: Lepu Biopharma Co., Ltd.

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Peking University Cancer Hospital
        • Kontakt:
          • Bin Zhang
    • Fujian
      • Fuzhou, Fujian, Kina, 350005
        • The First Affiliated Hospital of Fujian Medical University
        • Kontakt:
          • Gongbiao Lin
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun yat-sen University Cancer Center
        • Kontakt:
          • Xuekui Liu
      • Guangzhou, Guangdong, Kina, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Kontakt:
          • Jinsong Li
      • Shantou, Guangdong, Kina, 515041
        • Cancer Hospital of Shantou University Medical College
        • Kontakt:
          • Hanwei Peng
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • Guangxi Medical University Cancer Hospital
        • Kontakt:
          • Duoping Wang
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050011
        • The Fourth Hospital of Hebei Medical University
        • Kontakt:
          • Juan Li
    • Hubei
      • Wuhan, Hubei, Kina, 430079
        • Hubei Cancer Hospital
        • Kontakt:
          • Jian Chen
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital
        • Kontakt:
          • Hao Tian
      • Changsha, Hunan, Kina, 410008
        • Xiangya Hospital of Central South University
        • Kontakt:
          • Canhua Jiang
    • Liaoning
      • Shenyang, Liaoning, Kina, 110042
        • Liaoning Cancer Hospital & Institute
        • Kontakt:
          • Zhendong Li
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200120
        • Shanghai East Hospital
        • Kontakt:
          • Ye Guo
      • Shanghai, Shanghai Municipality, Kina, 200011
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Kontakt:
          • Yue He
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
        • Kontakt:
          • Chao Chen
      • Ningbo, Zhejiang, Kina, 315040
        • Ningbo Medical Center Lihuili Hospital
        • Kontakt:
          • Zhisen Shen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Life expectancy ≥ 6 months.
  2. Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
  3. At least one extracranial measurable lesion per RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  5. No severe cardiac dysfunction.
  6. Must provide tumor tissue sample not previously subjected to radiotherapy.
  7. Adequate organ function.
  8. Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

Exclusion Criteria:

  1. Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
  2. Head and neck cancer deemed non-resectable by the investigator.
  3. Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
  4. Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.
  5. Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities/complications. Minor procedures (e.g., vascular access placement, percutaneous/endoscopic head/neck biopsy, tracheostomy tube exchange) are allowed.
  6. Grade ≥2 peripheral neuropathy (CTCAE v5.0).
  7. Active autoimmune disease requiring systemic treatment within 2 years before first dose.
  8. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.
  9. Radiologically detectable central nervous system metastases and/or carcinomatous meningitis.
  10. Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.
  11. Any severe or uncontrolled systemic disease.
  12. Prior or planned allogeneic tissue/solid organ transplantation.
  13. Known hypersensitivity to any active ingredient or excipient of the study drugs.
  14. Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  15. Anti-infective therapy within 2 weeks before randomization.
  16. Stroke or transient ischemic attack within 6 months before enrollment.
  17. Uncontrolled or poorly controlled cardiac disease.
  18. Deep or intraluminal bleeding requiring interventional/surgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy.
  19. Pulmonary embolism or deep vein thrombosis within 3 months.
  20. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc.
  21. Received live vaccine within 30 days before first study dose.
  22. History of other primary malignancy.
  23. Positive serum pregnancy test or breastfeeding female.
  24. Contraindications to study drugs (pucotenlimab and/or becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues.
  25. Any condition that the investigator considers unsuitable for participation in the trial.
  26. Grade ≥2 hearing impairment per CTCAE v6.0.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Medicin: Becotatug Vedotin for Injection
Administrated intravenously
Medicin: Pucotenlimab Injection
Administrated intravenously
Placebo komparator: locally advanced resectable HNSCC Placebo +Pucotenlimab
Medicin: Pucotenlimab Injection
Administrated intravenously
Medicin: Placebo
Administrated intravenously

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Major Pathological Response (MPR) Rate
Tidsramme: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Pathological Complete Response (pCR) Rate
Tidsramme: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Event-Free Survival (EFS)
Tidsramme: From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Tidsramme: From date of randomization until death from any cause, assessed up to 36 months
From date of randomization until death from any cause, assessed up to 36 months
Preoperative Objective Response Rate (ORR)
Tidsramme: preoperative ORR will be assessed up to 12 weeks post-randomization
preoperative ORR will be assessed up to 12 weeks post-randomization
actual surgical resection rate
Tidsramme: surgical resection rate will be evaluated perioperatively
surgical resection rate will be evaluated perioperatively
R0 resection rate
Tidsramme: R0 resection rate will be confirmed up to 8 weeks postoperatively
R0 resection rate will be confirmed up to 8 weeks postoperatively
lymph node downstaging rate
Tidsramme: lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
Incidence of adverse events (AEs) and laboratory abnormalities assessed by CTCAE v6.0
Tidsramme: Within 30 days after last dose (30 days + 7 days window)
Within 30 days after last dose (30 days + 7 days window)
Serum Concentration
Tidsramme: From randomization through completion of therapy, up to 30 weeks
From randomization through completion of therapy, up to 30 weeks
Incidence of Anti-Drug Antibodies (ADA)
Tidsramme: From randomization through completion of therapy, up to 30 weeks
From randomization through completion of therapy, up to 30 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lepu Biopharma Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HX008/MRG003-C004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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