Penile Squamous Cell Carcinoma (PSCC)Phase 2SCOPENCT07907861
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) and Toripalimab in people with Penile Squamous Cell Carcinoma (PSCC) and Advanced Penile Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer, Metastatic Penile Cancer
- What is being tested?
- Sacituzumab Tirumotecan (SKB264) and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Jan 2030
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged 18 to 75 years
- Histologically or cytologically confirmed penile squamous cell carcinoma
- Unresectable locally advanced or metastatic penile squamous cell carcinoma (pT4, pN3, or M1, AJCC 8th edition TNM staging)
- Progression or recurrence after prior first-line platinum-based chemotherapy, or intolerance to platinum-based chemotherapy
- No previous treatment with PD-1/PD-L1 inhibitors
- At least one measurable lesion per RECIST version 1.1
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- ECOG performance status of 0 to 2; life expectancy of at least 6 months
- Adequate organ function (hematology, hepatic and renal function, cardiopulmonary function, and coagulation) meeting the safety standards for study drug administration
- Voluntary participation with signed written informed consent, good compliance, and willingness to comply with follow-up
Who cannot join
- Pure verrucous carcinoma of the penis, non-squamous penile malignancies, or squamous cell carcinoma primarily originating in the urethra
- Previous treatment with PD-1/PD-L1 inhibitors
- Previous treatment with a TROP2-directed antibody-drug conjugate
- Disease eligible for potentially curative resection in a participant able to tolerate radical surgery
- History or presence of interstitial lung disease, pulmonary fibrosis, or severe underlying pulmonary disease posing a high risk of TROP2-ADC-related pulmonary toxicity
- Severe cardiac, hepatic, renal, or neurological comorbidities that would preclude tolerance of study treatment
- Substance abuse, psychiatric illness, or poor compliance that would prevent adherence to study follow-up
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study
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
The First Affiliated Hospital of University of Science and Technology of China (West Campus) (Anhui Provincial Cancer Hospital)
Hefei, Anhui, 230031
Tao Tao, MD, +86188-5606-9828, taotao_urology@ustc.edu.cn
About this study
Official title: A Phase II, Single-center, Open-label Study of Sacituzumab Tirumotecan Combined With Toripalimab in Patients With Advanced Penile Squamous Cell Carcinoma Who Progressed On or Are Intolerant to Platinum-based Chemotherapy
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.
Read the detailed description
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.
- Conditions
- Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer, Metastatic Penile Cancer, Locally Advanced Penile Cancer
- Being tested
- Sacituzumab Tirumotecan (SKB264), Toripalimab
- Keywords
- SKB264, TROP2 antibody-drug conjugate, Toripalimab, PD-1 inhibitor, Platinum-refractory penile cancer, Chemotherapy-free, Immunotherapy combination, Phase 2 clinical trial, Single-arm study, Penile squamous cell carcinoma, Advanced penile cancer, Sacituzumab tirumotecan
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan (SKB264)Drug
Sacituzumab tirumotecan (SKB264) is a TROP2-targeted antibody-drug conjugate, administered intravenously at 4 mg/kg on Day 1 of each 2-week cycle.
ToripalimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SKB264 + Toripalimab | Experimental | 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. Receives: Drug: Sacituzumab Tirumotecan (SKB264); Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (before the first dose) until the safety follow-up visit at 28 ± 7 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Squamous Cell Carcinoma (PSCC)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China (West Campus), Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907861
- Sponsor's protocol ID
- SCOPE
- Acronym
- SCOPE
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-center, Open-label Study of Sacituzumab Tirumotecan Combined With Toripalimab in Patients With Advanced Penile Squamous Cell Carcinoma Who Progressed On or Are Intolerant to Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT07907861
- Acronym / sponsor ID
- SCOPE / SCOPE
- Conditions
- Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer, Metastatic Penile Cancer, Locally Advanced Penile Cancer
- Keywords
- SKB264, TROP2 antibody-drug conjugate, Toripalimab, PD-1 inhibitor, Platinum-refractory penile cancer, Chemotherapy-free, Immunotherapy combination, Phase 2 clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 30 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB264 + Toripalimab | Experimental | Drug: Sacituzumab Tirumotecan (SKB264), Drug: ToripalimabParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male, aged 18 to 75 years
- Histologically or cytologically confirmed penile squamous cell carcinoma
- Unresectable locally advanced or metastatic penile squamous cell carcinoma (pT4, pN3, or M1, AJCC 8th edition TNM staging)
- Progression or recurrence after prior first-line platinum-based chemotherapy, or intolerance to platinum-based chemotherapy
- No previous treatment with PD-1/PD-L1 inhibitors
Key exclusion criteria (8 listed)
- Pure verrucous carcinoma of the penis, non-squamous penile malignancies, or squamous cell carcinoma primarily originating in the urethra
- Previous treatment with PD-1/PD-L1 inhibitors
- Previous treatment with a TROP2-directed antibody-drug conjugate
- Disease eligible for potentially curative resection in a participant able to tolerate radical surgery
- History or presence of interstitial lung disease, pulmonary fibrosis, or severe underlying pulmonary disease posing a high risk of TROP2-ADC-related pulmonary toxicity
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 |
|---|---|---|
| Sacituzumab Tirumotecan (SKB264)Sacituzumab tirumotecan (SKB264) is a TROP2-targeted antibody-drug conjugate, administered intravenously at 4 mg/kg on Day 1 of each 2-week cycle. | Drug | SKB264 + Toripalimab |
| ToripalimabToripalimab 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. | Drug | SKB264 + Toripalimab |
Primary outcome
Objective Response Rate (ORR) per RECIST 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
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).
6 secondary outcomes
Disease Control Rate (DCR) per RECIST 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)
Time frame: From the first documented response until disease progression, death, or study completion, for up to approximately 24 months
Progression-Free Survival (PFS)
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)
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
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)
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
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The First Affiliated Hospital of University of Science and Technology of China (West Campus) (Anhui Provincial Cancer Hospital)
Hefei, China
Tao Tao, MD principal investigator
The First Affiliated Hospital of University of Science and Technology of China (West Campus), Anhui Provincial Cancer Hospital
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 Sacituzumab Tirumotecan (SKB264) and Toripalimab in people with Penile Squamous Cell Carcinoma (PSCC) and Advanced Penile Cancer, run by Anhui Provincial Hospital 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 8 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: opening soon, as of the sponsor's last update on 30 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) per RECIST 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). 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 30 Oct 2026.