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

7. juli 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Legemiddel: Becotatug Vedotin for Injection
Administrated intravenously
Legemiddel: Pucotenlimab Injection
Administrated intravenously
Placebo komparator: locally advanced resectable HNSCC Placebo +Pucotenlimab
Legemiddel: Pucotenlimab Injection
Administrated intravenously
Legemiddel: Placebo
Administrated intravenously

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Lepu Biopharma Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juli 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HX008/MRG003-C004

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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