EGFR-targeted therapy plus PD-1 blocker before surgery for advanced penile cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm phase II study evaluating neoadjuvant therapy with an EGFR-targeted antibody–drug conjugate (Becotatug vedotin) in combination with a PD-1 inhibitor (Pucotenlimab) for men with advanced penile squamous cell carcinoma. Eligible participants have EGFR-positive tumors, measurable disease, and disease that is difficult to treat with penile-sparing surgery or involves regional lymph nodes. The trial aims to determine tumor response, potential operability, and safety in the preoperative setting. Enrollment is at West China Hospital of Sichuan University, with Lepu Medical as a collaborator and Jiyan Liu as lead sponsor.

Why it matters

Who can join: the full rules

1. Inclusion Criteria （1）Histologically/cytologically confirmed penile squamous cell carcinoma (PSCC); （2）EGFR expression (IHC 1+, 2+, or 3+) confirmed by local pathology department; （3）No prior systemic therapy, or recurrence ≥6 months after adjuvant therapy for radical resection; （4）Male, aged ≥18 years; （5）Cytologically positive or clinically palpable inguinal lymphadenopathy, fixed mass, radiologically diagnosed pelvic lymph node metastasis, or penile preservation difficulty (unable to perform surgery with negative margin and functional penile stump preservation); （6）At least one measurable lesion per RECIST 1.1; （7）Adequate organ function:

   * Left ventricular ejection fraction (LVEF) ≥50%;
   * Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥3.0×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet (PLT) ≥80×10⁹/L;
   * Total bilirubin (TBIL) ≤1.5×ULN, AST/ALT ≤2.5×ULN (≤5×ULN for liver metastasis), serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min; （8）Voluntarily participate, understand the study, and sign informed consent form.
2. Exclusion Criteria （1）Prior systemic therapy (except recurrence ≥6 months after adjuvant chemotherapy for radical resection); （2）Severe concurrent diseases or poor physical condition unsuitable for treatment/surgery (e.g., severely ulcerated/infected inguinal lymph nodes with high risk of poor wound healing); （3）Uncontrolled comorbidities: uncontrolled infection, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (NYHA class III/IV heart failure, ≥grade 2 heart block, myocardial infarction within 12 months, unstable arrhythmia/angina, cerebral infarction within 6 months), interstitial lung disease, deep vein thrombosis/pulmonary embolism within 12 months, decompensated cirrhosis; （4）Active autoimmune diseases requiring systemic treatment within 2 years (except physiological replacement therapy); （5）Positive serological tests: HIV positive; HBsAg positive with HBV DNA ≥2000 copies/mL; HCV antibody positive with positive HCV RNA; （6）Major surgery within 4 weeks prior to enrollment, prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; （7）Vaccination with anti-tumor vaccine within 4 weeks prior to enrollment or planned during the study; （8）Other conditions deemed unsuitable by the investigator.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Hong-Shuai Li, Dr
• Email: lihongshuai456@163.com
• Phone: +86-18384262516

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Becotatug Vedotin Plus Pucotenlimab in EGFR-High Advanced Cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.