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Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer

NCT07767266 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-08-17

No results posted yet for this 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.

Conditions

  • Penile Cancer
  • Penile Squamous Cell Carcinoma (PSCC)

Interventions

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • The Affiliated Tumor Hospital of Xinjiang Medical University

    collaborator UNKNOWN

  • West China Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-15
Completion
2029-08-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767266 on ClinicalTrials.gov