CompletedPhase 1

A Clinical Trial of AdNRGM Plus CB1954 in Prostate Cancer

United Kingdom18 participantsStarted 2013-03-19

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who present with biopsy-proven local recurrence of prostate cancer following radical radiotherapy and a rising PSA with or without androgen suppression with antiandrogens or LHRH agonist/antagonist therapy or after bilateral orchidectomy. A rising PSA is defined as 2 increases over 3 or 4 readings over a minimum period of 6 weeks, with time-points separated by at least 2 weeks. If the patient is on antiandrogens or LHRH agonist/antagonist therapy, this therapy should be continued. * Life expectancy greater than 3 months. * Aged at least 18 years. * Written informed consent. * World Health Organisation (WHO) performance status of 0-1. * PSA value ≥ 2 and ≤ 100 ng/ml at study entry. * Adequate hepatic function (i.e. bilirubin, AST, ALT all \< 1.5 x upper limit of normal for Institution). * Normal renal function (\<1.25 x upper normal limit for the Institution). * Adequate haematological function (i.e. haemoglobin \> 10g/dl, WCC \> 3x109/l, platelets \> 150x10\^9/l) and normal clotting (INR and APTT \<1.2). * Patients must agree not to father a child within 12 months following AdNRGM administration, and must use at least two methods of contraception, one of which is barrier, starting from the time of AdNRGM administration for at least 12 months. * No known immuno-incompetence. Exclusion Criteria: * Patients with a prostate or abnormal focus which is deemed clinically unsuitable for trans-perineal template-guided injection. * Patients who have pr…

What they're measuring

Safety and tolerability of escalating doses of AdNRGM, followed by iv CB1954 determined by assessing local effects on tumour etc. and number of participants with treatment related adverse events by CTCAE v4.0

Timeframe: 12 months

Trial details

NCT IDNCT04374240

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08