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A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

NCT04374240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-11-03

No results posted yet for this study

Summary

This is an open label, non-randomised, phase I, sequential group trial which will explore the safety and tolerability of ascending doses of AdNRGM, in combination with CB1954. Five groups of 3 patients each will be treated with escalating doses of AdNRGM (10\^10, 3x10\^10, 10\^11, 3x10\^11, 10\^12 vp) followed 2 days later by intravenous CB1954 at a fixed dose (24mg/m\^2). To ensure the coverage of the whole prostate the vector will be delivered by multiple, template-guided trans-perineal injections using an adaptation of standard prostate brachytherapy technique. Dose escalation will be dependent on safety and tolerability; at each dose-level, if dose-limiting toxicity (DLT) is seen in one patient, the cohort will be expanded to a maximum of 6 patients. If DLT is then observed in a second patient at that dose, no further patients will be recruited and the previous (lower) dose-level will be defined as the maximum tolerated dose (MTD). If DLT is seen in 0/3 or just 1/6 patients, dose escalation may continue.

Conditions

Interventions

GENETIC

AdNRGM

AdNRGM is an E1-E3 deleted, replication deficient type 5 adenovirus which contains the E. coli NTR gene regulated by the CMV promoter, an internal ribosomal entry site (IRES) and the human GMCSF gene. CB1954 \[5-(aziridin-1-yl)-2,4-dinitrobenzamide\]

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Department of Health, United Kingdom

    collaborator OTHER_GOV

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Prashant Patel, FRCS Ed · University of Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-19
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374240 on ClinicalTrials.gov