Pucotenlimab plus Becotatug Vedotin: Neoadjuvant PD-1 inhibitor pucotenlimab (HX008) combine with EGFR ADC becotatug vedotin (MRG003) for locally advanced penile squamous cell carcinoma. Up to 4 Q3W neoadjuvant cycles; surgical patients receive 17-cycle adjuvant pucotenlimab.
Study summary
This is an open-label, multicenter, single-arm Phase 2 clinical trial evaluating neoadjuvant pucotenlimab (anti-PD-1 immunotherapy) combined with becotatug vedotin (EGFR-targeted antibody-drug conjugate, ADC) for adults with locally advanced penile squamous cell carcinoma. Eligible patients have high-risk disease defined as T4 primary tumor with any nodal status or any T stage with N2-N3 lymph node metastasis and no distant metastasis.
All participants receive up to 4 cycles of combination neoadjuvant therapy every 3 weeks. After treatment completion, a multidisciplinary team will assess if consolidative surgery can be performed. Patients who undergo surgery will continue single-agent pucotenlimab adjuvant treatment for 17 additional cycles (approximately 1 year).
The primary goal is to measure the pathological complete response (pCR) rate. Secondary goals include objective response rate (ORR), progression-free survival (PFS),overall survival (OS) and safty profiles. Blood and tumor tissue samples will be collected to explore biomarkers that may predict treatment response and drug resistance. A total of 29 male patients will be enrolled.
Eligibility
Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18-75 years, biologically male.
2. Histologically confirmed penile squamous cell carcinoma, stage T4 any N M0 or any T N2-N3 M0 without distant metastasis.
3. Treatment-naive; or relapsed patients with ≥12 months interval from last prior systemic therapy.
4. At least one measurable target lesion per RECIST 1.1.
5. ECOG performance status 0-2.
6. Adequate bone marrow, liver and renal function as predefined lab thresholds.
7. Expected survival ≥12 months.
8. No severe uncontrolled organ dysfunction.
9. Able to understand and voluntarily sign written informed consent.
Exclusion Criteria:
1. Pre-existing grade ≥2 peripheral neuropathy interfering daily activities.
2. Prior neoadjuvant therapy for penile cancer; previous use of PD-1/PD-L1 inhibitors or EGFR ADCs including becotatug vedotin.
3. Known hypersensitivity to pucotenlimab, becotatug vedotin or excipients.
4. Active malignancy within 5 years (excluding cured basal cell skin carcinoma and low-risk prostate cancer).
5. Uncontrolled severe cardiovascular disease, active hepatitis B/C, active infection requiring antibiotics within 2 weeks before enrollment.
6. Live vaccine administered within 30 days before first dosing.
7. HIV infection, autoimmune disease requiring systemic therapy within 2 years, long-term systemic immunosuppressants.
8. Other conditions judged by investigators to interfere with study treatment or assessment.
Primary outcome measure(s)
Pathological Complete Remission (pCR) Rate — Within 4 weeks after consolidative surgery Percentage of patients achieving pathological complete remission, defined as no residual invasive tumor cells in primary penile lesion and resected regional lymph nodes after neoadjuvant therapy and consolidative surgery.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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