Can a Two-Drug punch erase penile cancer before surgery?
NCT ID NCT07767266
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether combining two drugs—pucotenlimab, which helps the immune system attack cancer, and becotatug vedotin, which delivers a toxin directly to tumor cells—can eliminate advanced penile cancer before surgery. Men with high-risk, locally advanced penile squamous cell carcinoma will receive up to four cycles of the combination, followed by surgery if possible. The main goal is to see how many patients have no cancer cells left after treatment, with additional monitoring for long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pucotenlimab (an immunotherapy drug) combined with becotatug vedotin (a targeted cancer drug)
- What this could lead to
- If successful, this combination could shrink or eliminate advanced penile tumors before surgery, potentially improving long-term survival and offering a curative approach.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. Side effects from the drug combination could be significant, and the treatment may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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- New drug combo targets HPV-Driven cancers in phase II trial
- Double antibody attack: early trial combines immune and Growth-Signal blockers against advanced cancers
- Triple immunotherapy attack shows promise against Hard-to-Treat HPV cancers
- Promising drug cocktail aims to shrink penile cancer before surgery