A Phase 2 interventional study of Pucotenlimab plus Becotatug Vedotin in Penile Cancer and Penile Squamous Cell Carcinoma (PSCC), sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
Among 16 studies in Penile Neoplasms with a site in China — 12 open to participants now, 13 under way, 1 of them phase 3. Penile Neoplasms · China.
Among the 16 studies in Penile Neoplasms with a site in China, this one is the 10th largest by planned enrollment, is one of 5 that started in 2026, is one of 9 in phase 2, reaches primary completion later than 9 of the 12 other live ones, and was the 15th registered.
99 studies on the registry are indexed under Penile Neoplasms; 28 are open to participants now.
Browse Penile Neoplasms studies →12 of the 16 studies in Penile Neoplasms with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Jiyan Liu · Sites in China
Sun Yat-sen University · Sites in China
Jiyan Liu · Sites in China
Fudan University · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 23 Penile Neoplasms studies recruiting now, 18 (78%) set no upper age limit and 2 (9%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 5 started in 2026.
This study's planned enrollment of 29 is below the median of 37 across 81 interventional studies indexed under Penile Neoplasms.
Median enrollment 32 across the 16 interventional studies. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 16 have an industry lead sponsor. The 7 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
Sun Yat-sen University has 4 studies filed under Penile Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Penile Neoplasms with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06465914Phase 3Shanghai Bovax Biotechnology Co., Ltd.A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males | 2027-07-30 |
| NCT06684327Fudan UniversityMulti-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors | 2026-12-30 |
| NCT06683846Fudan UniversityIvonescimab in the Treatment of Multiple Advanced Tumors | 2027-11-30 |
Among the 16 studies in Penile Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Background:
Penile squamous cell carcinoma is a rare genitourinary malignancy with poor outcomes once regional lymph node spread occurs. Up to 45% of patients present with nodal metastasis at initial diagnosis. Patients with pelvic lymph node involvement (N3) have a 0-17% 5-year survival rate, and 86% of locally advanced patients experience recurrence within 2 years after standard surgery alone. The guidelines recommended neoadjuvant chemotherapy regimen (paclitaxel, ifosfamide, cisplatin, TIP) yields only a 10% pathological complete response rate, with limited long-term disease control and short survival after disease progression.
Over 90% of penile squamous cell carcinomas overexpress EGFR, and 40%-60% of patients show PD-L1 positivity, supporting dual targeting of EGFR and PD-1 as a promising therapeutic strategy. Preclinical and early clinical data confirm synergistic anti-tumor activity between EGFR ADCs and PD-1 inhibitors: the ADC payload promotes dendritic cell maturation and antigen presentation, while PD-1 blockade restores anti-tumor T cell function. Previous prospective trials demonstrate that this combination produces meaningful tumor regression and survival outcomes in other squamous cell carcinomas, with manageable toxicities.
This trial adopts a Simon two-stage single-arm design to efficiently test the study regimen's anti-tumor activity without a separate control group. If the first 10 enrolled patients show minimal pathological response, the trial will stop early for futility; otherwise, enrollment will continue to a total of 29 subjects to generate robust efficacy and safety data for this chemotherapy-free neoadjuvant platform.
Safety Oversight:
All adverse events are monitored from enrollment through 28 days after the last study drug dose, graded per CTCAE v5.0. All serious adverse events (SAEs) must be reported to the institutional review board and study sponsor within 24 hours. Standard supportive care, including growth factors for cytopenias, antihistamines and corticosteroids for infusion reactions, and symptom-directed management for immune-related toxicities and peripheral neuropathy, is permitted throughout treatment. Dose modification rules are pre-specified: pucotenlimab cannot be dose-reduced and may only be held or permanently discontinued, while becotatug vedotin allows one dose level reduction for persistent tolerability issues before permanent discontinuation.
A clinical trial liability insurance policy covers study participants for injuries causally related to investigational treatment, in accordance with Chinese clinical research regulations. A dedicated ethics committee hotline is available for participants to raise concerns regarding study participation, rights, or adverse events.
Biospecimen Research:
Collected blood and tumor tissue specimens are anonymized with unique study identifiers to protect participant privacy. No identifiable personal health information will be included in sequencing or laboratory testing. Biomarker analyses include HPV subtyping, PD-L1/EGFR immunohistochemistry, immune cell subset profiling, and multi-omic sequencing (single-cell transcriptomics, spatial transcriptomics, whole-exome and bulk RNA sequencing). Patient-derived xenograft (PDX) models will be established from residual tumor tissue to explore molecular mechanisms of treatment resistance. All biospecimens will be destroyed upon completion of planned exploratory analyses, with no long-term indefinite storage. Biomarker sub-study results will only be published in aggregate, without individual participant data disclosure.
Follow-Up:
After completing neoadjuvant and adjuvant therapy, participants enter a multi-year surveillance phase. Imaging assessments occur every 3-6 months for the first two years post-treatment completion, then annually from year three through year five. Remote telephone follow-up is allowed between scheduled hospital visits to track disease status, subsequent anti-cancer therapies, and overall survival. All participants who discontinue study treatment early-whether due to withdrawal, disease progression, or toxicity-remain in long-term survival follow-up to avoid missing survival endpoint data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm: Neoadjuvant pucotenlimab + becotatug vedotin, then adjuvant pucotenlimab for surgical patients. Max 4 neoadjuvant cycles (Q3W): Day1 pucotenlimab 3mg/kg (max 200mg, 60min IV), ≥30min later becotatug vedotin 2.0mg/kg (60-90min IV). Therapy stops early for progression/unmanageable toxicity. Post-neoadjuvant MDT assessment for consolidative surgery. Resectable patients receive 17 cycles of adjuvant pucotenlimab 200mg Q3W.
Drug: Pucotenlimab plus Becotatug Vedotin
Drug pages: Pucotenlimab · 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.
Pathological Complete Remission (pCR) Rate
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.
Time frame: Within 4 weeks after consolidative surgery
Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST 1.1 after neoadjuvant therapy.
Time frame: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of neoadjuvant treatment
Progression-Free Survival (PFS)
Time from study enrollment to first tumor progression or all-cause death.
Time frame: From the date of study enrollment until the date of first documented tumor progression or death from any cause (whichever occurs first), assessed up to 12 months
Overall Survival (OS)
Time from study enrollment to death from any cause.
Time frame: From the date of study enrollment to death from any cause, assessed up to 12 months
Incidence of Treatment-Related Adverse Events (TRAEs)
All-grade and Grade ≥3 TRAE incidence, type and severity graded by CTCAE v5.0.
Time frame: From enrollment to 28 days after last study treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
Of 28 phase 2 interventional studies under Penile Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 35. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pucotenlimab · Becotatug vedotin