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

Sponsor
Lepu Biopharma Co., Ltd.
Study ID
NCT07586124
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin for Injection — DRUG
    Administrated intravenously
  • Placebo — DRUG
    Administrated intravenously
  • Pucotenlimab Injection — DRUG
    Administrated intravenously

Study Details

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

Key Dates

First listed
May 14, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
  • Placebo Comparator: locally advanced resectable HNSCC Placebo +Pucotenlimab

Primary Outcome Measure

Major Pathological Response (MPR) Rate [ Time Frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks ]

Central Contacts

Find similar trials

Nationwide
Head and neck cancer trialsOncology trialsENT trials

Related Studies