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First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.

Adenocarcinoma of the Prostate Clinical Trial

Official title:
A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.

Clinical Trial Summary

This open label, dose escalating study is a phase I/IIa first in man study designed to evaluate the safety and tolerability of intratumoral administration of a novel oncolytic adenovirus (ORCA-010) in treating diagnosed treatment naïve Patients with localized prostate cancer.

Clinical Trial Description

The study is divided into two parts. In Part A of the study, cohorts of subjects will be administered escalating doses of ORCA-010, using the 3+3 design. When the Maximum Tolerated Dose has been determined in Part A, a group of 12 new subjects will be treated in Part B of the study at this dose, with two administrations separated by a 2-week interval. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04097002
Study type Interventional
Source Orca Therapeutics B.V.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 12, 2019
Completion date December 2024
View Details
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