Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder CancePhase 2NCT05356351

An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer

A Phase 2 study testing RC48- ADC in people with Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer.It's arm to evaluate the neoadjuvant treatment of Her2-positive Muscle-invasive Bladder Cancer in patients with objective response… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance
What is being tested?: RC48- ADC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 May 2022to 30 Jul 2027
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures
Patients with invasive bladder cancer are prepared for radical cystectomy (standard lymph node dissection);
Age ≥ 18 years old and ≤ 75 years old;
Clinical stage T2-T4aN0M0 (assessed by CT/MR/PET-CT);
Pathological was confirmed urothelial carcinoma by TURBT, HER2 overexpression confirmed by pathological biopsy: IHC2+ or IHC3+(central laboratory verification) andthe physical condition was not suitable for neoadjuvant chemotherapy ( pathological permit urothelial carcinoma Combined with other variant subtypes, with urothelial carcinoma as the main type) or refused neoadjuvant chemotherapy;
ECOG score ≤ 1;

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After TURBT, residual tumor (measurable according to RECIST 1.1 criteria) is present;
The important laboratory examination indexes meet the following requirements:
Hemoglobin ≥ 90g/L.
Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L.
Platelet ≥ 100 × 109 / L.
3.5mmol/L ≤ serum potassium ≤ 5.5mmol/L.
Liver function index: ALT, AST ≤ 1.5 times the upper limit of normal value (ULN), TBIL ≤ 1.5ULN.
Subjects with Serum creatinine≤ 1.5× ULN
The left ventricular ejection fraction (LVEF) was 50%.
Female subjects should be surgically sterilized or postmenopausal, or agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment and within 6 months after the end of the study treatment period. The blood pregnancy test must be negative within 7 days before the study, and it must be non-lactation. Male subjects should agree to use at least one medically approved contraceptive method (such as condoms, abstinence, etc.) during the study treatment period and within 6 months after the end of the study treatment period.

Who cannot join

Had received live attenuated vaccine or had serious infection or planned to receive any vaccine during the study period4 weeks before entering the group.
Received antineoplastic therapy within 6 months before the start of the study, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and clinical research antineoplastic drug therapy.
Uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.The results of HIVAb test were positive;with active bleeding or new thrombotic disease who are taking therapeutic anticoagulants or who have a tendency to bleed
Patients with RC48-ADC /PD-1 allergy or hypersensitivity, patients with autoimmune diseases;
HBsAg or HBcAb test results are positive, while HBVDNA copies are positive; HCVAb test results are positive (only if the PCR test result of HCVRNA is negative);Systemic corticosteroids or other systemic immunosuppressive drugs are used before enrollment, or systemic immunosuppressive drugs are expected to be needed during the trial;
Serious arteriovenous thrombosis or cardio-cerebrovascular accidents occurred within 1 year before administration, such as deep venous thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar infarction that is asymptomatic and does not require clinical intervention;with active bleeding or new thrombotic disease who are taking therapeutic anticoagulants or who have a tendency to bleed.

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Active/known/suspected autoimmune disease, history of primary immunodeficiency,Previous allogeneic hematopoietic stem cell transplantation;
Diagnosed with other malignancies within 5 years
Pregnant or lactating women.
Patients with missing main observation indicators, incomplete research data, incomplete follow-up data or failure to follow the research protocol

About this study

Read the detailed description

Objective response rate (ORR), Duration of response (DoR) (according to RECIST 1.1 Standard Edition)，progression-free survival (PFS), overall survival (OS), quality of life (QoL)and safety. Evaluation once every 2 weeks before cystectomy, If the efficacy results of the evaluation are complete response (CR) or partial response (PR), confirmed imaging efficacy at 9 weeks after the initial assessment ， efficacy evaluation time window of ± 14 days.

Conditions: Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance
Being tested: RC48- ADC

What participants receive

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

RC48- ADCDrug
Also called Triplizumab
RC48-ADC 2.0 mg/kg D1,Triplizumab 3mg/kg D2，Q2W

Study groups in NCT05356351
Study group	Role	What they receive
test group	Experimental	RC48-ADC 2.0 mg/kg）D1,Triplizumab 3mg/kg D2，Q2W Receives: Drug: RC48- ADC

What is being measured

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

Pathological response (PaR) rate
Pathological response (PaR) rate per central pathology review
Measured: Up to approximately 6 months
recommended dose for phase II safety (RP2D)
tolerability
Measured: Up to approximately 6 months
Incidence of adverse events and serious adverse events
safety
Measured: Up to approximately 6 months

Secondary outcomes (4)

The pathological complete response
The pathological complete response rate refers to all target lesions disappear
Measured: Up to approximately 6 months
Progression free survival
Follow-up was made after the first month after the operation, and then with an every three months until the tumor relapsed or progress
Measured: Up to approximately 24 months
Overall survival
The time from start of study treatment to date of death due to any cause
Measured: Up to approximately 48 months
Duration of response
This is the time from when the tumor begins to respond to treatment until the disease gets worse
Measured: Up to approximately 24 months

Timeline

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

1 May 202230 Jul 2027

First posted2 May 2022
Study start1 May 2022 (estimated)
Primary completion1 Jul 2023 (estimated)
Study completion30 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder CanceStudies of the same condition, open and under way.
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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05356351
Sponsor's protocol ID: RC48-TA001
Status last verified: Feb 2022
First submitted: 18 Apr 2022
Last updated: 2 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer
ClinicalTrials.gov ID: NCT05356351
Acronym / sponsor ID: RC48-TA001
Conditions: Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Collaborators: Xiangya Hospital of Central South University, First Affiliated Hospital Xi'an Jiaotong University, Southwest Hospital, China, Tongji Hospital, Chongqing University Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital of Air Force Medicial University
Study start: 1 May 2022 (estimated)
Primary completion: 1 Jul 2023 (estimated)
Study completion: 30 Jul 2027 (estimated)
First posted: 2 May 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

Study design

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

Arm	Type	Receives
test group	Experimental	Drug: RC48- ADCRC48-ADC 2.0 mg/kg）D1,Triplizumab 3mg/kg D2，Q2W

Who may qualify

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

Key inclusion criteria (16 listed)

The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures
Patients with invasive bladder cancer are prepared for radical cystectomy (standard lymph node dissection);
Age ≥ 18 years old and ≤ 75 years old;
Clinical stage T2-T4aN0M0 (assessed by CT/MR/PET-CT);
Pathological was confirmed urothelial carcinoma by TURBT, HER2 overexpression confirmed by pathological biopsy: IHC2+ or IHC3+(central laboratory verification) andthe physical condition was not suitable for neoadjuvant chemotherapy ( pathological permit urothelial carcinoma Combined with other variant subtypes, with urothelial carcinoma as the main type) or refused neoadjuvant chemotherapy;

Key exclusion criteria (10 listed)

Had received live attenuated vaccine or had serious infection or planned to receive any vaccine during the study period4 weeks before entering the group.
Received antineoplastic therapy within 6 months before the start of the study, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and clinical research antineoplastic drug therapy.
Uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.The results of HIVAb test were positive;with active bleeding or new thrombotic disease who are taking therapeutic anticoagulants or who have a tendency to bleed
Patients with RC48-ADC /PD-1 allergy or hypersensitivity, patients with autoimmune diseases;
HBsAg or HBcAb test results are positive, while HBVDNA copies are positive; HCVAb test results are positive (only if the PCR test result of HCVRNA is negative);Systemic corticosteroids or other systemic immunosuppressive drugs are used before enrollment, or systemic immunosuppressive drugs are expected to be needed during the trial;

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
RC48- ADCAlso: TriplizumabRC48-ADC 2.0 mg/kg D1,Triplizumab 3mg/kg D2，Q2W	Drug	test group

Primary outcome

Pathological response (PaR) rate
Time frame: Up to approximately 6 months
Pathological response (PaR) rate per central pathology review
recommended dose for phase II safety (RP2D)
Time frame: Up to approximately 6 months
tolerability
Incidence of adverse events and serious adverse events
Time frame: Up to approximately 6 months
safety

4 secondary outcomes

The pathological complete response
Time frame: Up to approximately 6 months
Progression free survival
Time frame: Up to approximately 24 months
Overall survival
Time frame: Up to approximately 48 months
Duration of response
Time frame: Up to approximately 24 months

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 2 May 2022.
Individual participant dataSharing planned: Yes

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 record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48- ADC in people with Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance, run by Tianjin Medical University Cancer Institute and Hospital.

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 10 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 2 May 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological response (PaR) rate (time frame: Up to approximately 6 months). The study lists 3 primary outcomes in all. 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 NCT05356351.

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 2 May 2022.