A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCandel Therapeutics, Inc.
About this trial
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must give study-specific informed consent prior to enrollment
Histologically confirmed adenocarcinoma of the prostate
Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)
Disqualifiers
Active liver disease, including known cirrhosis or active hepatitis
Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
Known HIV+ participants
Regional lymph node involvement or distant metastases
Trial design
Design model
Parallel
Treatments tested in this trial
aglatimagene besadenovec + valacyclovir
Biological/Vaccineaglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally.
External Beam Radiation Therapy (EBRT)
RadiationStandard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biodistribution of aglatimagene besadenovec
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
Time frame
Up to 5 months post last injection of aglatimagene besadenovec.Secondary outcomes
1
Biomarkers of immune activation and tumor burden
Evaluation of prostate-specific antigen (PSA) ng/mL changes over time.
Time frame
Up to 5 months post last injection of aglatimagene besadenovec.2
Biomarkers of immune activation and tumor burden
Evaluation of changes in lymphocytes as a proportion of total immune cells over time (lymphocytes/PBMCs).
Time frame
Up to 5 months post last injection of aglatimagene besadenovec.3
Biomarkers of immune activation and tumor burden
Changes from baseline in concentrations of circulating proteins (e.g. Olink Normalized Protein Expression, or NPX).
Time frame
Up to 5 months post last injection of aglatimagene besadenovec.4
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame
Up to 5 months post last injection of aglatimagene besadenovec.Sponsors and contacts
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Source ClinicalTrials.gov