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

Primary Purpose

Non-Muscle Invasive Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
VB4-845 Injection
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder.
  2. 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.
  3. The subject's disease is refractory or has relapsed following adequate BCG treatment.
  4. Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.
  5. All women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the first dose of study therapy.
  6. 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.
  7. Karnofsky performance status ≥ 60.
  8. Ability to understand and sign an Independent Ethics Committee-or Institutional Review Board-approved informed consent document.

Exclusion Criteria:

  1. The subject is pregnant or breastfeeding.
  2. Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years.
  3. Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding and diagnostic evaluation at Screening shows no evidence of tumor.
  4. Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
  5. 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.
  6. he subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment.
  7. A QTc interval of >470 msec by the Fridericia formula (QTcF), at the Screening ECG.
  8. 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).
  9. Local or severe allergy to any components of the drug regimen.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VB4-845 Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrence-free rate
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Complete response rate
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
Recurrence-free rate
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Frequency and severity of adverse events. Including adverse events (AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function, renal function, compelete blood count, and clinical chemistries.

Full Information

First Posted
April 13, 2021
Last Updated
April 21, 2021
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04859751
Brief Title
Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
Official Title
An Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Intravesical VB4-845 Injection in Patients With Non-Muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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
Detailed Description
Bladder cancer is the 6th most common cancer in the United States, affecting more men than women. The usual first treatment for NMIBC (Ta, T1,and CIS) is transurethral resection of the bladder tumors followed by intravesical immunotherapy, most commonly with bacillus Calmette-Guérin (BCG). Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS and high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. For patients unable or unwilling to undergo cystectomy, treatment options are limited. VB4-845 injection is a recombinant fusion protein produced in Escherichia coli (E. coli) that expresses a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to exotoxin A (ETA[252-608]). Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis. This is an open-label, non-randomized, multicenter bridging study in Chinese patients with NMIBC, specifically CIS (with or without papillary disease), high-grade Ta or any grade T1 papillary disease, who have previously failed BCG treatment (i.e., not those who are intolerant) with or without interferon. The study consists of a Screening period, a 12-week Induction Phase, and a Maintenance Phase of up to 21 monthly cycles for a total treatment period of up to104 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Muscle Invasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VB4-845 Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VB4-845 Injection
Intervention Description
Intravesical administration of VB4-845 Injection.
Primary Outcome Measure Information:
Title
Complete response rate
Description
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Recurrence-free rate
Description
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Time Frame
up to 6 months
Title
Complete response rate
Description
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
Time Frame
up to 3 months
Title
Recurrence-free rate
Description
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Time Frame
up to 3 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Description
Frequency and severity of adverse events. Including adverse events (AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function, renal function, compelete blood count, and clinical chemistries.
Time Frame
Every 4 weeks up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Kong, CMO
Phone
0531-83129659
Email
oliver.kong@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, PI
Organizational Affiliation
Shanghai Fudan University Affiliated Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, PI

12. IPD Sharing Statement

Plan to Share IPD
No

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

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