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Spots Global Cancer Trial Database for Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

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Trial Identification

Brief Title: Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

Official Title: A Phase I, Escalating Dose Study of VB6-845, a Recombinant Fusion Protein Targeting EpCAM, in Patients With Advanced Solid Tumours of Epithelial Origin

Study ID: NCT00481936

Interventions

VB6-845

Study Description

Brief Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin.

Detailed Description: The primary study objective of this Phase 1 trial was to determine the maximum tolerated dose (MTD) of VB6-845 and evaluate the safety and tolerability of VB6-845 when administered as a monotherapy intravenous (IV) infusion (over 3 hours), once weekly in 4-week cycles, to subjects with EpCAM positive advanced solid tumours of epithelial origin. Secondary objectives included evaluating the pharmacokinetic profile and immunogenicity of VB6-845 and assessing exploratory efficacy of VB6-845. Dose cohorts of 3-6 subjects with EpCAM positive advanced solid tumours of epithelial origin are to be entered into the study. The starting dose is defined as 1.00 mg/kg, which is 1/10 of the no observed adverse effect level (NOAEL) reached in preclinical studies. Doses are to be escalated according to the modified Fibonacci design until 2 out of 3 or 2 out of 6 subjects experienced a Dose Limiting Toxicity (DLT). The MTD is to be reached when \<2 out of 6 subjects experienced a DLT. An additional 12 subjects are to be enrolled at the MTD for further characterization of VB6-845 at that level. Regardless of dose cohort, subjects are to continue to receive treatment until an unacceptable toxicity occurred, all lesions completely disappeared or disease progression is determined.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chemotherapy and Immunotherapy clinic Medulla, Tbilisi, , Georgia

Blokhin Cancer Research Centre, Department of Chemotherapy and Combined therapy, Moscow, , Russian Federation

Blokhin Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy, Moscow, , Russian Federation

Moscow City Oncology Hospital #62, Moscow, , Russian Federation

Non state Institution of Ministry of Health "Central Clinical Hospital #2 named after N.A. Semashko" of Open-joint stock company "Russian Railways", Moscow, , Russian Federation

Yaroslavl Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation

Contact Details

Name: Wendy Cuthbert

Affiliation: Sesen Bio, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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