Payload Information

General Information of This Payload
Payload ID
PAY0UCFUY
Name
Pseudomonas exotoxin ETA-252-608
Synonyms
Pseudomonas exotoxin ETA-252-608
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Target(s) Eukaryotic elongation factor 2 (EEF2)
 Target Info 
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
Oportuzumab monatox [Phase 3]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Complete Remission (CR)
44.44% (all)
41.91% (in cohort 1)
39.13% (in cohort 2)
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  Phase 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 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Complete Remission (CR)
39.94% (in all patients)
29.41% (In the TIS% (in situ carcinoma) group)
43.75% (In the T1 group)
42.86% (In the Ta group)
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 3 Reporting the Activity Date of This ADC [3]
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 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 2 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 3 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.

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