Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer

NCT04859751 | Unknown Phase 3

• 1 other identifier: VB4-845-CN-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. VB4-845 injection is an experimental agent that may provide an alternative to cystectomy

Conditions

Non-Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy

  up to 6 months

Secondary Outcomes (4)

• Recurrence-free rate

  up to 6 months

• Complete response rate

  up to 3 months

• Recurrence-free rate

  up to 3 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Every 4 weeks up to 104 weeks

Study Arms (1)

VB4-845 Injection

EXPERIMENTAL

Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.

Drug: VB4-845 Injection

Interventions

VB4-845 Injection DRUG

Intravesical administration of VB4-845 Injection.

VB4-845 Injection

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder.
• Subjects must have received adequate BCG treatment defined as at least 2 courses of BCG, i.e., at least one induction and one maintenance course or at least 2 induction courses.
• The subject's disease is refractory or has relapsed following adequate BCG treatment.
• Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.
• All women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the first dose of study therapy.
• All sexually active subjects agree to use barrier contraception (i.e., condoms) while receiving study treatment and for 120 days following their last dose of study treatment.
• Karnofsky performance status ≥ 60.
• Ability to understand and sign an Independent Ethics Committee-or Institutional Review Board-approved informed consent document.

You may not qualify if:

• The subject is pregnant or breastfeeding.
• Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years.
• Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding and diagnostic evaluation at Screening shows no evidence of tumor.
• Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
• History of recurrent severe urinary tract infections (UTIs) per investigator judgment. Subjects with a current UTI requiring antibiotic treatment may defer the initiation of Vicinium treatment on Day 1 until resolution of the UTI.
• he subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment.
• A QTc interval of \>470 msec by the Fridericia formula (QTcF), at the Screening ECG.
• Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s).
• Local or severe allergy to any components of the drug regimen.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

VB4-845

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

• Dingwei Ye, PI

  Shanghai Fudan University Affiliated Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Kong, CMO

CONTACT

0531-83129659; oliver.kong@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: March 23, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)