NCT07497919

A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer

A Multicenter, Single-Arm, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer in Patients Who Are Intolerant to Chemotherapy or Have Failed Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

Penile cancer is a rare malignant tumor of the male genitourinary system, with 95% being squamous cell carcinoma. Due to social factors, delayed diagnosis is common, leading to a high rate of lymph node metastasis (17%-45% at diagnosis), which significantly impairs quality of life and prognosis. The 5-year survival rate is 27% for patients with lymph node metastasis and 0%-17% for those with pelvic lymph node metastasis (N3). Current standard treatments recommended by guidelines include surgery and chemotherapy. However, the neoadjuvant TIP regimen (paclitaxel + ifosfamide + cisplatin) in locally advanced disease yields an objective response rate (ORR) of 50%, pathological complete response (pCR) rate of 10%, median progression-free survival (PFS) of 8.1 months, and median overall survival (OS) of 17.1 months. For advanced patients, no standard effective treatments exist after platinum-based chemotherapy resistance, highlighting an urgent need for more effective combination therapies. High expression of PD-L1 (30%-70%) and EGFR (40%-80%) is common in penile squamous cell carcinoma, especially in poorly differentiated, late-stage disease with lymph node metastasis. A prospective phase II study showed that toripalimab (immunotherapy) combined with nimotuzumab (anti-EGFR antibody) and paclitaxel-based chemotherapy, followed by consolidation surgery, achieved an ORR of 82.8%, pCR rate of 48.3%, 2-year OS rate of 72.4%, and 2-year PFS rate of 65.5%; 41.4% of patients had grade 3-4 treatment-related adverse events, with no treatment-related deaths. Although immune checkpoint inhibitors and anti-EGFR targeted therapy demonstrate preliminary antitumor activity in advanced penile cancer, their clinical efficacy remains suboptimal with substantial toxicities, thus warranting the development of more effective combinatorial therapeutic strategies.

Detailed description

This trial will evaluate the efficacy and safety of Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb) as first-line therapy in the treatment of EGFR-Positive advanced penile cancer in patients who are intolerant to chemotherapy or have failed chemotherapy. Becotatug Vedotin (2.3 mg/kg, IV, Q3W) and Pucotenlimab (200 mg, IV, Q3W) will be administrated on enrolled patients. Treatment continues until disease progression, intolerable toxicity, withdrawal, death, or sponsor termination. After treatment completion, all patients will undergo survival follow-up every 3 months until death, loss to follow-up, consent withdrawal, or study termination by the sponsor.

Conditions

• Penile Cancer

Interventions

Type	Name	Description
DRUG	Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)	Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2026-03-27
• Last updated: 2026-03-27