Bladder CancerPhase 4NCT05488353

A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma

A Phase 4 study testing Disitamab Vedotin for Injection,Penpulimab Injection in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Bladder Cancer
What is being tested?: Disitamab Vedotin for Injection,Penpulimab Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 1 Sep 2022to 30 Apr 2026
Phase: Phase 4
Are there results?: None posted in the registry

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily participate in this trial, be able to sign a written informed consent form, and understand and agree to comply with the requirements of this study and the evaluation schedule.
The age on the date of signing the informed consent form is 18 to 75 years old.
If it is a patient with cT2-T4aNxM0 bladder urothelial carcinoma with histological diagnosis and imaging evaluation based on AJCC eighth edition bladder cancer TNM staging, if the investigator believes that there is residual disease after TURBT surgery; the histology is mixed type. Oncological patients require urothelial carcinoma predominance (at least 50%).
Patients who are intolerant or not receiving cisplatin must be determined by the investigator. Patients who do not tolerate cisplatin chemotherapy must meet at least one of the following criteria:
The performance status of ECOG is >1;
Creatinine clearance rate < 60mL/min;

Show all 16Show fewer

Hearing loss ≥ grade 2 in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5th edition;
Peripheral neuropathy grade ≥ 2 in NCI-CTCAE 5th edition;
Suffering from New York Heart Association grade 3 or higher heart failure.
According to the assessment by the investigator, the need for radical cystectomy after neoadjuvant therapy, and the indications for radical cystectomy are met, and they are willing to undergo the surgery.
HER2 testing at local laboratory using pre-treatment tumor specimens: HER2 expression confirmed after IHC results (defined as: IHC 1+ 2+ 3+).
ECOG fitness status 0~1.
The patient's organ function is good, as measured by the following screening laboratory values ??(obtained ≤14 days prior to enrollment):
Patients should not be on growth factor support ≤ 14 days prior to sample collection when screening for: i. Absolute neutrophil count ≥1.5×109/L; ii. Platelets≥100×109/L; iii. Hemoglobin≥90g/L; b. International normalized ratio or activated partial thromboplastin time ≤ 1.5 upper limit of normal (ULN); c. Serum total bilirubin≤1.5×ULN; d. AST, ALT and alkaline phosphatase≤2.5×ULN; e. The calculated creatinine clearance rate is greater than 30 mL/min;
Non-conceptual or fertile women must be willing to use highly effective contraception during the study period and for ≥ 120 days after the last dose of Vidicitumumab or Piamprizumab (whichever occurs later), and Negative urine or serum pregnancy test results within ≤7 days prior to enrollment.
Non-sterilized males must be willing to use highly effective contraception during the study period and for ≥ 120 days after the last dose of vildicotumab or pianiprilumab (whichever occurs later).

Who cannot join

Previously received therapies targeting PD-1, PD-L1, PD-L2, CTLA4, Her2 or other antibodies or drugs that specifically target T cell co-stimulation or checkpoint channels.
Received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor) within 28 days before enrollment.
Previously received radiotherapy for bladder cancer.
Received drug treatment for tumors in the past, except for the following:
For patients who have received systemic chemotherapy in the past, a treatment-free interval of at least 12 months from the last treatment to the start of neoadjuvant drug therapy;
Local intravesical chemotherapy or immunotherapy ended at least 1 week before the initiation of study neoadjuvant drug therapy.

Show all 19Show fewer

Major surgery or major trauma within 28 days before enrollment (implantation of vascular access device and TURBT are not considered major surgery).
Serious infection requiring systemic antibacterial, antifungal or antiviral treatment within 14 days before enrollment (HBV infection is performed according to the instructions of exclusion criterion 12).
Have been vaccinated with live vaccines within 28 days before enrollment (seasonal influenza vaccines are usually inactivated vaccines, so they are allowed to be used. Intranasal vaccines are live vaccines, so they are not allowed to be used).
Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment.
Active autoimmune disease that requires systemic treatment, and the investigator evaluates that it has an impact on the study treatment.
Long-term use of large amounts of hormones or other immunosuppressive agents is required, and the investigator evaluates that it has an impact on the study treatment.
History of potassium, sodium, calcium abnormalities or hypoalbuminemia, interstitial lung disease, non-infectious pneumonia, or other uncontrolled systemic diseases, including diabetes, hypertension, cardiovascular disease, that the investigator believes may affect treatment (such as active heart disease within 6 months before enrollment, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug treatment, etc.), etc.
Untreated chronic hepatitis B subjects or hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) are not allowed to enter the study. Note: Inactive hepatitis B surface antigen carriers or patients with stable active HBV infection (HBV DNA <500 IU/mL [2500 copies/mL]) after continuous antiviral therapy can be enrolled. HBV DNA testing is performed only in patients who are positive for antibodies to hepatitis B surface antigen.
Patients with active hepatitis C are not eligible. Patients who tested negative for HCV antibodies during the screening period, or those who tested negative for HCV RNA after positive HCV antibody tests could be enrolled. Only patients who test positive for HCV antibodies require HCV RNA testing.
A history of immunodeficiency (including positive human immunodeficiency virus HIV test, other acquired and congenital immunodeficiency diseases) or a history of allogeneic stem cell transplantation or organ transplantation.
Known hypersensitivity to other monoclonal antibodies.
Known allergy to any study drug or excipient.
Concurrently participate in another therapeutic clinical study.

Trial locations and contacts

No sites are listed yet.

Tianxin Lin contact

86-20-34070379

sys_urology_gcp@163.com

About this study

This study is a one-arm exploratory clinical study of Disitamab Vedotin for Injection combined with Penpulimab Injection designed for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients.It will confirme the efficacy and safety of Disitamab Vedotin for Injection combined with Penpulimab Injection neoadjuvant treatment for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients. Finally, it will provide new evidence-based medical evidence for neoadjuvant therapy for such patients.

Read the detailed description

This study is a multicenter, open-label, single-arm prospective clinical study to evaluate the neoadjuvant treatment of Disitamab Vedotin for Injection combined with Penpulimab Injection in cisplatin-intolerant cT2-T4aNxM0 bladder urothelial carcinoma Efficacy and safety in patients. If the subject does not withdraw from the trial voluntarily, the toxic and side effects caused by the drug are intolerable, or the investigator believes that the subject is not suitable for further trials, each subject will undergo the following treatment after surgery, and in Efficacy evaluation and follow-up were performed in each cycle.

After completion of all screening activities, patients who are identified as eligible will enter the study and receive the following treatments and visits: Neoadjuvant therapy with Disitamab Vedotin for Injection combined with Penpulimab Injection (administered for a maximum of 4 cycles), every three One week is a medication cycle; patients received radical cystectomy after neoadjuvant chemotherapy; postoperative pathological complete remission rate, downstaging rate, and regular follow-up for two years were evaluated to evaluate the safety of the patients drugs/surgery, and to evaluate the patients new Survival after curative resection with adjuvant immunotherapy combined with chemotherapy.

Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Surgical plan: radical cystectomy + urinary diversion.

Conditions: Bladder Cancer
Being tested: Disitamab Vedotin for Injection,Penpulimab Injection
Keywords: HER2-expressing, Cisplatin-intolerant, Disitamab Vedotin for Injection, Penpulimab Injection
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Disitamab Vedotin for Injection,Penpulimab InjectionDrug
After completion of all screening activities, patients confirmed to be eligible will enter the study and receive the following treatments.
Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Study groups in NCT05488353
Study group	Role	What they receive
Single Arm	Experimental	Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection. Receives: Drug: Disitamab Vedotin for Injection,Penpulimab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

pCR rate
As assessed by the investigator,proportion of patients without residual tumor lesion among patients who underwent radical cystectomy after completion of clinical trial treatment.
Measured: 12 months

Secondary outcomes (4)

pathological downstaging rate
The pathological downstaging rate is judged according to the pathological results after surgery whether the downstaging is below T2 stage.
Measured: 12 months
safety evaluation
Safety is evaluated by monitoring and recording all adverse events graded as NCI-CTCAE V5.0 or Clavien-Dindo.
Measured: up to 3 years
EFS EFS
Event-free survival (EFS) is the time from the start of the first neoadjuvant therapy to disease progression, death from any cause, or new development of other tumors.
Measured: up to 3 years
OS
Overall survival (OS) is defined as the time from the start of treatment to death from any cause.
Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202230 Apr 2026

First posted4 Aug 2022
Study start1 Sep 2022 (estimated)
Primary completion30 Apr 2026 (estimated)
Study completion30 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05488353
Sponsor's protocol ID: RC48-C039
Status last verified: Aug 2022
First submitted: 1 Aug 2022
Last updated: 4 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
preliminary safety and efficacy results of RC48 combined with toripalimab in patients wit local advaned or metastatic Urothelial carcinoma(NCT04264936,RC48-C014)
An Open-label, Single-arm, Multicenter, Phase II Study of RC48 to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (NCT03809013,RC48-C009)
Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.
PubMed 33109737
Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible

Want to know more?

Tianxin Lin

86-20-34070379

sys_urology_gcp@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma
ClinicalTrials.gov ID: NCT05488353
Acronym / sponsor ID: RC48-C039
Conditions: Bladder Cancer
Keywords: HER2-expressing, Cisplatin-intolerant, Disitamab Vedotin for Injection, Penpulimab Injection
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 48 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Collaborators: Third Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Southern Medical University, China, The Third Affiliated Hospital of Southern Medical University
Study start: 1 Sep 2022 (estimated)
Primary completion: 30 Apr 2026 (estimated)
Study completion: 30 Apr 2026 (estimated)
First posted: 4 Aug 2022 (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.

Detailed description

Surgical plan: radical cystectomy + urinary diversion.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: Disitamab Vedotin for Injection,Penpulimab InjectionDisitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Voluntarily participate in this trial, be able to sign a written informed consent form, and understand and agree to comply with the requirements of this study and the evaluation schedule.
The age on the date of signing the informed consent form is 18 to 75 years old.
If it is a patient with cT2-T4aNxM0 bladder urothelial carcinoma with histological diagnosis and imaging evaluation based on AJCC eighth edition bladder cancer TNM staging, if the investigator believes that there is residual disease after TURBT surgery; the histology is mixed type. Oncological patients require urothelial carcinoma predominance (at least 50%).
Patients who are intolerant or not receiving cisplatin must be determined by the investigator. Patients who do not tolerate cisplatin chemotherapy must meet at least one of the following criteria:
According to the assessment by the investigator, the need for radical cystectomy after neoadjuvant therapy, and the indications for radical cystectomy are met, and they are willing to undergo the surgery.

Key exclusion criteria (19 listed)

Previously received therapies targeting PD-1, PD-L1, PD-L2, CTLA4, Her2 or other antibodies or drugs that specifically target T cell co-stimulation or checkpoint channels.
Received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2 and tumor necrosis factor) within 28 days before enrollment.
Previously received radiotherapy for bladder cancer.
Received drug treatment for tumors in the past, except for the following:
Major surgery or major trauma within 28 days before enrollment (implantation of vascular access device and TURBT are not considered major surgery).

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
Disitamab Vedotin for Injection,Penpulimab InjectionAfter completion of all screening activities, patients confirmed to be eligible will enter the study and receive the following treatments. Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.	Drug	Single Arm

Primary outcome

pCR rate
Time frame: 12 months
As assessed by the investigator,proportion of patients without residual tumor lesion among patients who underwent radical cystectomy after completion of clinical trial treatment.

4 secondary outcomes

pathological downstaging rate
Time frame: 12 months
safety evaluation
Time frame: up to 3 years
EFS EFS
Time frame: up to 3 years
OS
Time frame: up to 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Backgroundpreliminary safety and efficacy results of RC48 combined with toripalimab in patients wit local advaned or metastatic Urothelial carcinoma(NCT04264936,RC48-C014)
BackgroundAn Open-label, Single-arm, Multicenter, Phase II Study of RC48 to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (NCT03809013,RC48-C009)
Background: PubMed 33109737Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.
BackgroundAntitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible
Individual participant dataSharing planned: No

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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. This study is not recruiting at the moment.

Tianxin Lin contact

86-20-34070379

sys_urology_gcp@163.com

Tianxin Lin principal investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Disitamab Vedotin for Injection,Penpulimab Injection in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tianxin Lin (86-20-34070379, sys_urology_gcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488353, which also lists 5 linked publications.

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 4 Aug 2022.