Penile CancerPhase 2NCT07497919
A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer
A Phase 2 study testing Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb) in people with Penile Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- Histologically confirmed penile squamous cell carcinoma with evidence of metastasis, and EGFR expression confirmed positive by immunohistochemistry (IHC).
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST): non-lymph node lesions with a longest diameter ≥ 10 mm on computed tomography (CT) scan, or lymph node lesions with a short axis diameter ≥ 15 mm on CT scan; or evaluable cutaneous lesions per World Health Organization (WHO) criteria.
- Have received at least one prior line of chemotherapy, or be deemed chemotherapy-intolerant by the investigator.
- Adequate organ and bone marrow function, as defined by the following laboratory criteria within the screening period:
Show all 9Show fewer
- 1)Hemoglobin > 8.5 g/dL, without blood transfusion or erythropoietin administration within the preceding 14 days; 2)Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, without granulocyte colony-stimulating factor administration within the preceding 14 days; 3)Platelet count (PLT) ≥ 90 × 10⁹/L, without blood transfusion within the preceding 14 days; 4)Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (for patients with Gilbert's syndrome, ≤ 3 × ULN is permitted); 5)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (if liver metastasis is present, ALT and AST ≤ 5 × ULN is permitted); 6)Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula); 7)Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; 8)Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range; subjects with an abnormal baseline TSH but normal total T3 (or FT3) and FT4 levels are also eligible.
- 7.Expected survival of more than 3 months.
- -
Who cannot join
- Diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Prior treatment with an ADC drug containing monomethyl auristatin E (MMAE) as the cytotoxic moiety, or prior treatment with a PD-(L)1 inhibitor.
- Currently participating in an interventional clinical study, or having received other investigational agents or investigational device therapy within 4 weeks prior to the first dose.
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
- Major surgical procedure (excluding biopsy-only procedures) within 4 weeks prior to the first dose of study drug, or anticipated major surgery during the study period.
- Hereditary bleeding tendency, coagulation disorder, or history of thrombosis.
Show all 18Show fewer
- History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to the active ingredients or excipients of the study drugs vibecotamab and putelimab.
- Inadequate recovery from toxicity and/or complications caused by any prior intervention (i.e., ≤ Grade 1 or baseline levels, excluding fatigue or alopecia) before starting treatment.
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibody).
- Untreated active hepatitis B (defined as positive HBsAg plus HBV-DNA copy number above the upper limit of normal of the local laboratory).
- Note: Subjects with hepatitis B meeting the following criteria are eligible: HBV viral load < 1000 copies/mL (200 IU/mL) before the first dose; subjects must receive anti-HBV therapy throughout the study treatment period to prevent viral reactivation.
- For subjects who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.
- Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection).
- Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1).
- Note: Administration of inactivated seasonal influenza vaccine via injection within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not allowed.
- Presence of any severe or uncontrolled systemic disease, such as:
- 1)Clinically significant and symptomatic uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting electrocardiogram (ECG), e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; 2)Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥ 2; 3)Uncontrolled hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg); 4)Active pulmonary tuberculosis; 6)Active or uncontrolled infection requiring systemic therapy; 7)Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 8)Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 9)Uncontrolled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L); 10)Urine routine test showing urine protein ≥ ++, confirmed 24-hour urinary protein quantification > 1.0 g; 14.Psychiatric disorders that prevent compliance with study treatment; Any other medical history, evidence of disease, treatment, or abnormal laboratory value that could interfere with study results, prevent the subject from completing the study, or for which the investigator considers the subject to be otherwise ineligible or at potential risk for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
SU, MD, 86-021-64175590, suhengchuan@163.com
Su
About this study
Official title: 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
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.
Read more
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.
Read the 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
- Being tested
- Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)Drug
Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin plus Pucotenlimab | Experimental | Not described Receives: Drug: Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 12 weeks
Secondary outcomes (3)
PFS
Measured: 12 weeks
Overall survival (OS)
Measured: 12 weeks
Disease control rate (DCR)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Sep 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Province Tumor Hospital, Shanghai GoBroad Cancer Hospital, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Dingwei Ye, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497919
- Sponsor's protocol ID
- 2603341-13
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07497919
- Acronym / sponsor ID
- 2603341-13
- Conditions
- Penile Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fujian Province Tumor Hospital, Shanghai GoBroad Cancer Hospital, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin plus Pucotenlimab | Experimental | Drug: Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- Histologically confirmed penile squamous cell carcinoma with evidence of metastasis, and EGFR expression confirmed positive by immunohistochemistry (IHC).
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST): non-lymph node lesions with a longest diameter ≥ 10 mm on computed tomography (CT) scan, or lymph node lesions with a short axis diameter ≥ 15 mm on CT scan; or evaluable cutaneous lesions per World Health Organization (WHO) criteria.
- Have received at least one prior line of chemotherapy, or be deemed chemotherapy-intolerant by the investigator.
Key exclusion criteria (18 listed)
- Diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Prior treatment with an ADC drug containing monomethyl auristatin E (MMAE) as the cytotoxic moiety, or prior treatment with a PD-(L)1 inhibitor.
- Currently participating in an interventional clinical study, or having received other investigational agents or investigational device therapy within 4 weeks prior to the first dose.
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
- Major surgical procedure (excluding biopsy-only procedures) within 4 weeks prior to the first dose of study drug, or anticipated major surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Becotatug Vedotin plus Pucotenlimab |
Primary outcome
Objective response rate (ORR)
Time frame: 12 weeks
3 secondary outcomes
PFS
Time frame: 12 weeks
Overall survival (OS)
Time frame: 12 weeks
Disease control rate (DCR)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Penile Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Not yet recruitingPhase 2
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dingwei Ye principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb) in people with Penile Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hengchuan Su (021-6417 5590, suhengchuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.