A Phase 2 interventional study of Sacituzumab Tirumotecan (SKB264) and Toripalimab in Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer and Metastatic Penile Cancer, sponsored by Anhui Provincial Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Anhui Provincial Hospital · Phase 2, Interventional, and Treatment
This is a single-center, single-arm, open-label, Phase 2 clinical trial (the SCOPE study) evaluating the efficacy, safety, and tolerability of sacituzumab tirumotecan (SKB264) combined with toripalimab as a second-line, chemo-free treatment for patients with unresectable locally advanced or metastatic penile squamous cell carcinoma whose disease progressed on or who are intolerant to platinum-based chemotherapy.
Penile squamous cell carcinoma (PSCC) is a rare and aggressive cancer with limited treatment options once disease progression occurs after initial platinum-based chemotherapy, and standard second-line approaches leave tumors shrinking or disappearing in only 10-15% of cases. Sacituzumab tirumotecan is an antibody-drug conjugate (ADC) designed to target TROP-2, a protein expressed on the surface of nearly all penile cancer cells. By binding to TROP-2, sacituzumab tirumotecan delivers a chemotherapy payload directly to the tumor cells. Toripalimab is an immunotherapy drug (a PD-1 inhibitor) that helps the body's immune system find and attack cancer cells, and combining an ADC with a PD-1 inhibitor may work better than either drug alone. All participants in this trial will receive both study drugs via intravenous (IV) infusion on Day 1 of each 2-week cycle, toripalimab first, followed by sacituzumab tirumotecan about 30 minutes later, for as long as the treatment is helping them and the side effects are tolerable.
The main goal of this study is to determine the percentage of participants whose tumors shrink or disappear after receiving the combination (Objective Response Rate). The study will also measure how long the responses last (Duration of Response), how long participants live without their cancer getting worse (Progression-Free Survival), how long participants live overall (Overall Survival), the percentage of participants whose disease is controlled (Disease Control Rate), and the side effects of the combination.
Penile squamous cell carcinoma (PSCC) is a rare and aggressive cancer. After first-line platinum-based chemotherapy, nearly all patients eventually develop resistance, and no standard second-line therapy exists; available options provide objective response rates of only 10-15% and a median overall survival of less than 10 months. TROP-2 is highly expressed in PSCC, with membrane expression reported in up to 98% of primary tumors and expression preserved in metastatic lesions. Sacituzumab tirumotecan (SKB264) is a TROP2-targeted antibody-drug conjugate (ADC) whose payload can diffuse into neighboring cells, helping overcome antigen heterogeneity. Toripalimab is a PD-1 inhibitor with established activity in solid tumors. Early data support the chemo-free "ADC plus immunotherapy" strategy in platinum-failed PSCC and related tumors.
This is a prospective, single-center, single-arm, open-label, exploratory Phase 2 trial (the SCOPE study). Thirty-one adult male patients with unresectable locally advanced or metastatic PSCC who progressed on, recurred after, or were intolerant to platinum-based chemotherapy, and who have not received prior PD-1/PD-L1 inhibitors, will receive toripalimab 3 mg/kg IV followed approximately 30 minutes later by sacituzumab tirumotecan 4 mg/kg IV on Day 1 of each 2-week cycle, until disease progression or unacceptable toxicity.
The primary endpoint is the objective response rate (ORR) per RECIST v1.1, assessed by the investigator using imaging performed every 3 cycles. Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety per CTCAE v5.0, and patient-reported outcomes (EORTC QLQ-C30). Exploratory analyses will assess tumor TROP-2 H-score, PD-L1 CPS, CD8+ T-cell infiltration, ctDNA dynamics, and HPV status, and their correlation with clinical outcomes.
99 studies on the registry are indexed under Penile Neoplasms; 28 are open to participants now.
This study's planned enrollment of 31 is below the median of 37 across 81 interventional studies indexed under Penile Neoplasms.
Browse Penile Neoplasms studies →Anhui Provincial Hospital is the lead sponsor of 135 studies on the registry; 101 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Participants receive toripalimab 3 mg/kg intravenously on Day 1 of each 2-week cycle, followed approximately 30 minutes later by sacituzumab tirumotecan (SKB264) 4 mg/kg intravenously on Day 1 of each 2-week cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of informed consent, or investigator-determined discontinuation.
Drug: Sacituzumab Tirumotecan (SKB264) · Drug: Toripalimab
Sacituzumab tirumotecan (SKB264) is a TROP2-targeted antibody-drug conjugate, administered intravenously at 4 mg/kg on Day 1 of each 2-week cycle.
Toripalimab is a PD-1 inhibitor, administered intravenously at 3 mg/kg on Day 1 of each 2-week cycle. No dose reduction is performed; immune-related adverse events are managed by continuing treatment, holding, or permanently discontinuing the drug according to severity.
Objective Response Rate (ORR) per RECIST 1.1
Description: The objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1 based on imaging (enhanced MRI of the penis and inguinal region, and enhanced CT of the chest, abdomen, and pelvis).
Time frame: From the first dose of study drug until disease progression, death, or study completion, with imaging performed every 3 treatment cycles (approximately every 6 weeks), for up to 24 months
Disease Control Rate (DCR) per RECIST 1.1
The disease control rate is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.
Time frame: From the first dose of study drug until disease progression, death, or study completion, with imaging performed every 3 treatment cycles (approximately every 6 weeks), for up to 24 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response (CR or PR) to the date of first documented disease progression or death from any cause, whichever occurs first. Participants without progression or death are censored at the last valid tumor assessment.
Time frame: From the first documented response until disease progression, death, or study completion, for up to approximately 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of first documented disease progression or death from any cause, whichever occurs first. Participants without progression or death are censored at the last valid tumor assessment.
Time frame: From the first dose of study drug until disease progression, death, or study completion, for up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from the date of the first dose of study drug to the date of death from any cause. Participants alive at the end of the study are censored at the date last known to be alive.
Time frame: From the first dose of study drug until death or study completion, with follow-up approximately every 3 months after the end of treatment, for up to approximately 24 months
Incidence of Adverse Events Graded by CTCAE v5.0
The incidence, severity, and causality of adverse events, serious adverse events, and immune-related adverse events, including those leading to dose modification, treatment interruption, permanent discontinuation, or death, will be summarized. Laboratory abnormalities (hematology, hepatic and renal function, cardiac enzymes, and pulmonary function) will also be monitored.
Time frame: From the date of signing the informed consent form until 28 days after the last dose of study drug (or the start of a new anticancer treatment, whichever occurs first); study-drug-related serious adverse events are followed for up to 90 days after the la
Patient-Reported Outcomes Measured by EORTC QLQ-C30 (Version 3.0)
Health-related quality of life will be assessed using the Chinese version of the EORTC QLQ-C30 (version 3.0) questionnaire. Scores of the functional scales, symptom scales, and global health status will be described at baseline, during treatment, and at the safety follow-up visit.
Time frame: From baseline (before the first dose) until the safety follow-up visit at 28 ± 7 days after the last dose of study drug
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2029, 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sacituzumab tirumotecan