Trial · NCT07907861
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
NCT07907861, Phase 2, Not yet recruiting, Anhui Provincial Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy. Trials, record NCT07907861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07907861
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
- NCT number
- NCT07907861
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 31 participants, estimated
- Lead sponsor
- Anhui Provincial Hospital
- Conditions
- Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer, Metastatic Penile Cancer, Locally Advanced Penile Cancer
- Interventions
- Sacituzumab Tirumotecan (SKB264), Toripalimab
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) per RECIST 1.1 | 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 | 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). |
| Secondary | Disease Control Rate (DCR) per RECIST 1.1 | 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 | 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. |
| Secondary | Duration of Response (DoR) | From the first documented response until disease progression, death, or study completion, for up to approximately 24 months | 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. |
| Secondary | Progression-Free Survival (PFS) | From the first dose of study drug until disease progression, death, or study completion, for up to approximately 24 months | 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. |
| Secondary | Overall Survival (OS) | 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 | 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. |
| Secondary | Incidence of Adverse Events Graded by CTCAE v5.0 | 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 | 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. |
| Secondary | Patient-Reported Outcomes Measured by EORTC QLQ-C30 (Version 3.0) | From baseline (before the first dose) until the safety follow-up visit at 28 ± 7 days after the last dose of study drug | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07907861
GET https://conductscience.org/api/trials/v1/NCT07907861/registered