General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ICRYT
ADC Name
VB4-845
Synonyms
4D5MOCB-ETA; Anti-ECAM exotoxin A fusion protein; B-4845; Oportuzumab monatox; Proxinium; VB-4847; VB-845; VB4-845; Vicineum; Vicinium; Vysyneum; oportuzumab monatox-qqrs
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Organization
Sesen Bio; Qilu Pharmaceutical Co., Ltd.; Baxter Oncology GmbH; Viventia Bio, Inc.
Drug Status
Phase 3
Antibody Name
Oportuzumab
 Antibody Info 
Antigen Name
Epithelial cell adhesion molecule (EPCAM)
 Antigen Info 
Payload Name
Pseudomonas exotoxin ETA-252-608
 Payload Info 
Therapeutic Target
Eukaryotic elongation factor 2 kinase (EEF2K)
 Target Info 
Linker Name
Undisclosed
Conjugate Type
Amide bonds of recombinant proteins.
Combination Type
Monatox
Special Approval(s)
Fast track (FDA)
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
Indication Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 New Drug Application Approved
Urothelial cancer
1 Trials
Trial ID
NCT03258593
1 Trials
Trial ID
NCT00462488
2 Trials
Trial ID
NCT04859751
NCT02449239
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 12 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Maximum Observed Concentration (Cmax) 18±25 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

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[1]
Area Under the Concentration-Time Curve (AUC) 59±83 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

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[1]
Maximum Observed Concentration (Cmax) 202±349 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

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[1]
Area Under the Concentration-Time Curve (AUC) 1407±2436 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

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[1]
Maximum Observed Concentration (Cmax) 102±127 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

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[1]
Area Under the Concentration-Time Curve (AUC) 1039±1385 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

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[1]
Maximum Observed Concentration (Cmax) 1051±1639 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 3132±4172 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Maximum Observed Concentration (Cmax) 258±261 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1203±1063 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Maximum Observed Concentration (Cmax) 2646±4081 pg/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 7847±12034 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
Distribution
Click To Hide/Show 6 Distribution Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 59±83 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1407±2436 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1039±1385 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 3132±4172 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1203±1063 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 7847±12034 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
Metabolism
Click To Hide/Show 6 Metabolism Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 59±83 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1407±2436 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1039±1385 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 3132±4172 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1203±1063 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 7847±12034 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
Excretion
Click To Hide/Show 12 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 59±83 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 3.76 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 20 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1407±2436 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 4.6 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 40 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1039±1385 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 4.73 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 80 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 3132±4172 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 2.6±1.66 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 130 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 1203±1063 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 4.66 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 200 ug.

   Click to Show/Hide
[1]
Area Under the Concentration-Time Curve (AUC) 7847±12034 pg*h/mL
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
Elimination Half-Life (t1/2) 3.46±1.35 h
A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck, 280 ug.

   Click to Show/Hide
[1]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 7 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT00462488
PHASE2
Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical ViciniumTM in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)

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Undisclosed  NCT02449239
PHASE3
Open-Label, Multicenter, Ph 3 [Phase 3] Study to Evaluate the Efficacy and Tolerability of Intravesical ViciniumTM in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG

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Undisclosed  NCT03258593
PHASE1
A Phase I Single-Arm Study of the Combination of Durvalumab (MEDI4736) and Vicineum (Oportuzumab Monatox, VB4-845) in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

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Undisclosed  NCT04859751
PHASE3
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
Complete Remission (CR)  NCT00462488
Phase 2
Phase 2 study to evaluate the efficacy and tolerability of intravesical vicinium in patients with non-invasive urothelial carcinoma in situ (CIS) previously treated with bacille calmette-gurin (BCG).
Complete Remission (CR)  Undisclosed
Phase 1
An open-label, multicenter, dose-escalating trial of intravesically administered VB4-845. Eight dose levels were initially evaluated, starting at 0.10 mg once weekly for 6 consecutive weeks and escalating through 0.20, 0.33, 0.66, 1.32, 2.64, 5.28, and 10.56 mg/dose. The maximum tolerated dose (MTD) was not reached; therefore, an additional escalation through 13.73, 17.85, 23.20, and 30.16 mg was undertaken. Each dose was administered to the bladder through a catheter and held for 2 h prior to voiding.

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Undisclosed  Undisclosed
Phase 1
An open-label, multicenter, single-arm dose-escalating trial assessing the safety and tolerability of VB4-845 injected IT once weekly for four consecutive weeks. Twenty patients were treated in six dose cohorts, and were followed for four weeks after the last dose. The ascending modifi ed Fibonacci dose cohorts were 100, 200, 330, 500, 700, and 930 g. VB4-845 was supplied as a 1 mg/mL formulation and was diluted in phosphate buffered saline.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 7 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Inclusion: Adults (&ge;18y) with EpCAM+ CIS bladder TCC failing BCG therapy (last 24 months), residual unresectable disease post-TURBT, life expectancy &ge;12 months, adequate organ function. Exclusion: Upper tract TCC/hydronephrosis, recent intravesical therapy (<2 months), active UTIs, uncontrolled comorbidities, pregnancy, or inability to tolerate intravesical procedures. Contraception required for reproductive-age patients.

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Administration Dosage
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
Related Clinical Trial
NCT Number NCT00462488  Clinical Status PHASE2
Clinical Description Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical ViciniumTM in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)
Primary Endpoint
A complete response to oportuzumab monatox was seen in 9 of 22 patients (41%) in cohort 1 and 9 of 23 (39%) in cohort 2 at the 3-month evaluation. A total of 20 patients (44%) achieved a complete response. Two other patients without carcinoma in situ who achieved a complete response were not included in the study due to the development of noninvasive papillary (Ta) disease. Median time to recurrence in patients who achieved a complete response was 274 and 408 days in cohorts 1 and 2, respectively. Overall 7 patients (16%) remained disease-free. Post-study assessment demonstrated that these patients were still disease-free at last followup (18 to 25 months).

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Other Endpoint
The most common adverse events were mild to moderate reversible bladder symptoms.
Experiment 2 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Eligibility: BCG-refractory/relapsed non-muscle-invasive bladder cancer (CIS/Ta/T1) patients (&ge;18y) with adequate organ function, stratified by disease type/time since BCG. Exclusions: upper tract TCC/hydronephrosis, recent chemotherapy (<2 weeks), active UTIs, QTc>470ms, uncontrolled comorbidities, or second malignancies (except localized/low-risk cancers). Contraception required during treatment +120 days.

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Administration Dosage
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.
Related Clinical Trial
NCT Number NCT02449239  Clinical Status PHASE3
Clinical Description Open-Label, Multicenter, Ph 3 [Phase 3] Study to Evaluate the Efficacy and Tolerability of Intravesical ViciniumTM in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG
Primary Endpoint
Primary endpoints include complete response rate (CRR) at 3 months (absence of high-grade disease confirmed by cytology/cystoscopy) and duration of response (time from CR to treatment failure/death) assessed up to 24 months in CIS patients receiving Vicinium therapy.
Other Endpoint
Secondary endpoints comprise event-free survival (time to disease recurrence/progression/cystectomy/death), CRR at 3-month intervals (6-24 months), time to cystectomy (up to 48 months), progression-free/overall survival (24/48 months respectively), and safety (AE incidence/treatment discontinuations monitored for 25 months).
Experiment 3 Reporting the Activity Date of This ADC [4]
Patients Enrolled
Eligibility: BCG-unresponsive NMIBC (CIS/Ta/T1) patients (&ge;18y, ECOG 0-1) with adequate organ function. Exclusions: prior PD-1/PD-L1 therapy, active infections/autoimmunity, QTc&ge;470ms, other malignancies (except localized cancers), hydronephrosis, or immunosuppressant use within 28 days. Contraception required during/4 months post-treatment.
Administration Dosage
.
Related Clinical Trial
NCT Number NCT03258593  Clinical Status PHASE1
Clinical Description A Phase I Single-Arm Study of the Combination of Durvalumab (MEDI4736) and Vicineum (Oportuzumab Monatox, VB4-845) in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
Primary Endpoint
Safety assessment includes incidence and severity of adverse events (Grades 1-5 per CTCAE v5.0) recorded over an average 315-day period, covering non-serious AEs to life-threatening/serious events (hospitalization, disability, death).
Other Endpoint
Efficacy and biomarker analyses evaluate urinary EpCAM/PD-L1/PD-1 changes between responders/non-responders (Wilcoxon tests), pharmacokinetics (urinary Vicineum Cmax), disease-free survival (Kaplan-Meier), and immune parameter dynamics in blood/biopsies at baseline/3/6 months. Response criteria include cytology/cystoscopy-confirmed recurrence/progression.

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Experiment 4 Reporting the Activity Date of This ADC [5]
Patients Enrolled
Eligibility: BCG-refractory/relapsed non-muscle-invasive bladder cancer patients (&ge;18y, Karnofsky&ge;60) with adequate prior BCG exposure (&ge;2 courses). Exclusions: upper tract disease, active hydronephrosis, recent chemotherapy (<2 weeks), QTc>470ms, concurrent malignancies, or intravesical procedure intolerance. Contraception required during/120 days post-treatment.

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Administration Dosage
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.
Related Clinical Trial
NCT Number NCT04859751  Clinical Status PHASE3
Clinical Description 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
Primary Endpoint
Primary efficacy endpoints include complete response rate (CRR) at 3 and 6 months in CIS patients (with/without papillary disease) receiving VB4-845 therapy, assessed through cystoscopic and pathological evaluation.
Other Endpoint
Secondary endpoints comprise recurrence-free rates at 3/6 months for high-grade Ta/T1 patients, along with comprehensive safety monitoring (CTCAE v5.0-graded AEs, lab abnormalities, vital signs) throughout the 104-week study duration.
Experiment 5 Reporting the Activity Date of This ADC [6]
Efficacy Data Complete Remission (CR)
44.44
40.91
39.13 %
Patients Enrolled
Histologically confirmed TCC of the bladder and residual CIS, with or without concurrent Ta or T1 tumors, refractory/intolerant to 1 or more cycles of BCG in the 24 months before enrollment and whose tumor was EpCAM positive.
Administration Dosage
1 induction cycle of 6 (cohort 1) or 12 (cohort 2) weekly intravesical oportuzumab monatox (VB4-845) instillations of 30 mg, followed by up to 3 maintenance cycles of 3 weekly administrations every 3 months; lasting up to 1 year.
Related Clinical Trial
NCT Number NCT00462488  Clinical Status Phase 2
Clinical Description Phase 2 study to evaluate the efficacy and tolerability of intravesical vicinium in patients with non-invasive urothelial carcinoma in situ (CIS) previously treated with bacille calmette-gurin (BCG).
Primary Endpoint
Evaluable patients treated with OM 44.44% (20 of 45) achieved a CR.
Other Endpoint
A complete response to oportuzumab monatox was seen in 9 of 22 patients (40.91%) in cohort 1 and 9 of 23 (39.13%) in cohort 2 at the 3-month evaluation. A total of 20 patients (44.44%) achieved a complete response.
Experiment 6 Reporting the Activity Date of This ADC [7]
Efficacy Data Complete Remission (CR)
39.94
29.41
43.75
42.86 %
Patients Enrolled
Immunohistochemically confirmed EpCAM-positive Grade 2 or 3 nonmuscle invasive bladder cancer (NMIBC) (Ta, T1, in situ carcinoma [TIS]), either refractory to (recurrence within 2 years following at least one complete cycle of BCG therapy) or intolerant of BCG therapy.
Administration Dosage
Eight dose levels were initially evaluated, starting at 0.10 mg once weekly for 6 consecutive weeks and escalating through 0.20, 0.33, 0.66, 1.32, 2.64, 5.28, and 10.56 mg/dose. Each dose was administered to the bladder through a catheter and held for 2 h prior to voiding.
Experiment 7 Reporting the Activity Date of This ADC [8]
Patients Enrolled
Histologically confirmed recurrent squamous cell carcinomas of the head and neck (SCCHN) following radiotherapy and/or chemotherapy.
Administration Dosage
Twenty patients were treated in six dose cohorts, and were followed for four weeks after the last dose. The ascending modified Fibonacci dose cohorts were 100, 200, 330, 500, 700, and 930 ug. Injected IT once weekly for four consecutive weeks.
References
Ref 1 A phase I clinical study of intratumorally administered VB4-845, an anti-epithelial cell adhesion molecule recombinant fusion protein, in patients with squamous cell carcinoma of the head and neck
Ref 2 Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
Ref 3 Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Ref 4 Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
Ref 5 Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
Ref 6 A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Gurin. J Urol. 2012 Nov;188(5):1712-8.
Ref 7 A Phase I study of an intravesically administered immunotoxin targeting EpCAM for the treatment of nonmuscle-invasive bladder cancer in BCGrefractory and BCG-intolerant patients. Drug Des Devel Ther. 2010 Nov 15;4:313-20.
Ref 8 A phase I clinical study of VB4-845: weekly intratumoral administration of an anti-EpCAM recombinant fusion protein in patients with squamous cell carcinoma of the head and neck. Drug Des Devel Ther. 2009 Feb 6;2:105-14.