A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec

Candel Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Treatments

Biological: aglatimagene besadenovec + valacyclovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT07332000

PrTK05

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must give study-specific informed consent prior to enrollment
Histologically confirmed adenocarcinoma of the prostate
Participants meeting National Comprehensive Cancer Network (NCCN) favorable, intermediate-risk criteria
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
18 years of age or older
Performance status must be Eastern Cooperative Oncology Group 0-2
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
Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
Known HIV+ participants
Regional lymph node involvement or distant metastases
Participants planning to receive whole pelvic irradiation
Other current malignancy (except squamous or basal cell skin cancers)
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.
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.
Participants who had or plan to have orchiectomy as the form of hormonal ablation
Known sensitivity or allergic reactions to acyclovir or valacyclovir