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

7 juli 2026 uppdaterad 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Läkemedel: Becotatug Vedotin for Injection
Administrated intravenously
Läkemedel: Pucotenlimab Injection
Administrated intravenously
Placebo-jämförare: locally advanced resectable HNSCC Placebo +Pucotenlimab
Läkemedel: Pucotenlimab Injection
Administrated intravenously
Läkemedel: Placebo
Administrated intravenously

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Major Pathological Response (MPR) Rate
Tidsram: 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

Sekundära resultatmått

Resultatmått
Tidsram
Pathological Complete Response (pCR) Rate
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: surgical resection rate will be evaluated perioperatively
surgical resection rate will be evaluated perioperatively
R0 resection rate
Tidsram: 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
Tidsram: 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
Tidsram: Within 30 days after last dose (30 days + 7 days window)
Within 30 days after last dose (30 days + 7 days window)
Serum Concentration
Tidsram: 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)
Tidsram: From randomization through completion of therapy, up to 30 weeks
From randomization through completion of therapy, up to 30 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Lepu Biopharma Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 juli 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

30 april 2026

Först inskickad som uppfyllde QC-kriterierna

7 maj 2026

Första postat (Faktisk)

14 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HX008/MRG003-C004

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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