A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Purpose
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, favorable intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).
Condition
- Prostate Cancer Patients Treated by Radiotherapy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must give study-specific informed consent prior to enrollment 2. Histologically confirmed adenocarcinoma of the prostate 3. Participants meeting National Comprehensive Cancer Network (NCCN) favorable, intermediate-risk criteria 4. Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT and able to tolerate multiple transrectal ultrasound guided injections 5. 18 years of age or older 6. Performance status must be Eastern Cooperative Oncology Group 0-2 7. The following laboratory criteria must be met: 1. Aspartate aminotransferase (AST) < 3 x upper limit of normal 2. Serum creatinine < 2 mg/dL 3. Calculated creatinine clearance > 30 mL/min 4. White blood cells > 3000/mm3 5. Platelets >100,000/mm3
Exclusion Criteria
- Active liver disease, including known cirrhosis or active hepatitis 2. Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs 3. Known HIV+ participants 4. Regional lymph node involvement or distant metastases 5. Participants planning to receive whole pelvic irradiation 6. Other current malignancy (except squamous or basal cell skin cancers) 7. Other serious co-morbid illness or compromised organ function that, in the opinion of the Investigator, would interfere with treatment or follow-up. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease. 8. Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator. 9. Participants who had or plan to have orchiectomy as the form of hormonal ablation 10. Known sensitivity or allergic reactions to acyclovir or valacyclovir
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Patients receiving the experimental drug |
|
Recruiting Locations
Towson 4371582, Maryland 4361885 21204
Las Vegas 5506956, Nevada 5509151 89144
Saddle Brook 5103637, New Jersey 5101760 07663
More Details
- Status
- Recruiting
- Sponsor
- Candel Therapeutics, Inc.
Study Contact
Detailed Description
This is a phase 2a, open-label, multi-center study evaluating aglatimagene besadenovec plus prodrug in men with localized, favorable intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT). Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral antiviral prodrug (valacyclovir), this approach induces targeted tumor cell death and stimulates a systemic immune response. The study aims to characterize: - Viral shedding and biodistribution of CAN-2409 genomes in blood, urine, and semen using validated qPCR assays. - Immune activation biomarkers, including lymphocyte subsets, cytokine profiles, and circulating tumor-related proteins. Approximately 30 patients with favorable risk prostate cancer and will receive 3 courses of injections of aglatimigene besadenovec followed by valacyclovir. EBRT will start after the second injection. Biospecimens (blood, urine, semen) will be collected before and after each injection to assess biodistribution and immune response. Safety will be monitored continuously. Frequency of treatment-emergent adverse events (TEAEs) and laboratory values will be evaluated.