Spots Global Cancer Trial Database for A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer

Study Description

Brief Summary: A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in patients with prostate cancer.

Detailed Description: Mobilan is a nanoparticle-formulated, recombinant non-replicating adenovirus immunotherapeutic drug that directs expression of both toll-like receptor 5 (TLR5) and a specific agonistic ligand, entolimod (which is a recombinant form of the natural TLR5 ligand, flagellin). The viral construct infects cells expressing the Coxsackie virus and adenovirus receptor (CAR), which has been shown in preclinical studies to be highly expressed in human prostatic tissue, including prostate cancer tissue. Upon infection, co-expression of both receptor and ligand in the same transfected cell triggers persistent autocrine stimulation of the nuclear factor-kappa B (NF-κB) signaling cascade. In a syngeneic mouse prostate cancer model, prostatic injection of Mobilan leads to activation of an innate immune response with infiltration of neutrophils and natural killer cells (NK) cells and induction of an adaptive immune response, comprising cytotoxic (cluster of differentiation \[CD\]8+) T cells. Necrotic changes in tumor cells were observed in Mobilan-treated animals with concomitant reductions in prostatic volume. Mobilan also show anti-metastatic activity in a surgical adjuvant mouse model of prostate cancer. This clinical trial is a Phase Ib double-blinded, randomized, placebo-controlled trial evaluating the efficacy, safety, and pharmacology of either 1 or 2 injections of Mobilan or placebo when administered as neoadjuvant therapy directly into the prostates of patients with newly diagnosed prostate cancer. All study subjects will receive 2 study drug injections administered 2 weeks apart and will be randomly allocated in a 1:1:1 ratio to 1 of the following 3 drug administration schedules: * Arm A: Mobilan on both Day 1 and on Day 15. * Arm B: Placebo on Day 1 and Mobilan on Day 15. * Arm C: Placebo on both Day 1 and Day 15 Subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

Keywords

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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