RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer

NCT05996952 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023(24)
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.

Conditions

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• 12-month recurence-free survival rate

  The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment

  From treatment initiation to 12 month

• 3-month pathological complete response rate

  The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment

  From treatment initiation to 3 month

• Adverse events

  The type, incidence, relatedness, and severity of adverse events

  From patient screening to 30 days after end of cycle 6

Secondary Outcomes (6)

• 6-month recurence-free survival rate

  From treatment initiation to 6 month

• Duration of response

  From time of complete response to up to 60 months

• Recurrence-free survival

  From time of first dose of RC48-ADC adjuvant treatment to up to 60 months

• Progression-free survival

  From time of first dose of RC48-ADC treatment to up to 60 months

• Overall survival

  From time of first dose of RC48-ADC treatment to up to 60 months

Study Arms (2)

Adjuvant RC48-ADC

EXPERIMENTAL

In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.

Drug: RC48-ADC

Salvage RC48-ADC

EXPERIMENTAL

In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment.

Drug: RC48-ADC

Interventions

RC48-ADC DRUG

Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.

Adjuvant RC48-ADC; Salvage RC48-ADC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Life expectancy ≥12 weeks.
• Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
• Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
• Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
• Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
• Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Demonstrate adequate organ function.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
• Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

You may not qualify if:

• Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
• Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
• Allergic to study therapy.
• Has a known additional malignancy that has had progression or has required active treatment in the last five years.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
• Has had an allogeneic tissue/solid organ transplant.

Sponsors & Collaborators

• West China Hospital: lead
• RemeGen Co., Ltd.: collaborator

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hao Zeng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zeng

CONTACT

8602885422114; kucaizeng@163.com

Junru Chen

CONTACT

8602885422114; jrchen@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 18, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)