A Clinical Study of RC48-ADC Combined With Triplizumab For Treatment of Myometrial Invasive Bladder Cancer

NCT05016973 | Unknown Phase 2

• 1 other identifier: IUNU-UC-102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to explore whether Monoclonal Antibody-MMAE Conjugate for Injection (RC48-ADC) combined with Triplizumab as a preoperative neoadjuvant therapy for myometrial invasive bladder cancer (MIBC) can achieve a good tumor descending period, so as to prolong disease-free survival and overall survival.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological response (PaR) rate per central pathology review

  Up to approximately 6 months

Secondary Outcomes (4)

• The pathological complete response rate refers to all target lesions disappear.

  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.

  Up to approximately 48 months

• OS (Overall survival): The time from start of study treatment to date of death due to any cause.

  Up to approximately 48 months

• Adverse reaction rate: from the beginning of the study subjects receiving treatment, the adverse reactions caused by the treatment were recorded in detail. The adverse events that have not disappeared after chemotherapy should be followed up.

  Up to approximately 48 months

Study Arms (1)

RC48-ADC+ Triplizumab

EXPERIMENTAL

RC48-ADC on days 1 every 21 days plus triplizumab on days 1 every 21 days

Drug: RC48-ADC; Drug: Triplizumab

Interventions

RC48-ADC DRUG

2.0mg/kg, Intravenous drip on days 1 every 21 days

Also known as: Disitamab vedotin

RC48-ADC+ Triplizumab

Triplizumab DRUG

240mg, Intravenous drip on days 1 every 21 days

RC48-ADC+ Triplizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with myometrial invasive bladder cancer are prepared for radical cystectomy;
• HER2 overexpression confirmed by pathological biopsy: IHC2+ or IHC3+; subjects can provide tumor samples detected by HER2;
• Age ≥ 18 years old and ≤ 80 years old;
• Tumor clinical stage is (c) T2-3bN0M0;
• ECOG score ≤ 1;
• Subjects have not received systemic chemotherapy, ADC drugs or immunotherapy.
• The important laboratory examination indexes meet the following requirements:
• Hemoglobin ≥ 90g/L.
• Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L.
• Platelet ≥ 100 × 109 / L.
• mmol/L ≤ serum potassium ≤ 5.5mmol/L.
• Liver function index: ALT, AST ≤ 1.5 times the upper limit of normal value (ULN), TBIL ≤ 1.5ULN.
• eGFR ≥ 50 mL/min
• The left ventricular ejection fraction (LVEF) was 50%.
• Subjects with serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50mL/min

You may not qualify if:

• Patients who cannot tolerate radical cystectomy;
• patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).
• 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.
• Patients with drug allergy or hypersensitivity, patients with autoimmune diseases;
• Received antineoplastic therapy within 3 weeks before the start of the study, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and clinical research antineoplastic drug therapy.
• Had received live attenuated vaccine or had serious infection or planned to receive any vaccine during the study period one month before entering the group.
• Systemic corticosteroids or other systemic immunosuppressive drugs are used within 2 weeks before enrollment, or systemic immunosuppressive drugs are expected to be needed during the trial;
• Serovirological examination (based on the normal value of the research center):
• 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).
• The results of HIVAb test were positive.
• Heart failure classified as grade 3 or above by the New York College of Cardiology (NYHA);
• Active or progressive infections that require systematic treatment, such as active pulmonary tuberculosis;
• Systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.
• 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;
• Previous allogeneic hematopoietic stem cell transplantation;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

disitamab vedotin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Hongqian Guo, MD

CONTACT

8613605171690; dr.ghq@nju.edu.cn

Rong Yang, MD

CONTACT

13851924716; doctoryr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 23, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CN (1)