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Also known as aglatimagene besadenovec, Aglatimagene besadenovec, Aglatimagene Besadenovec
aglatimagene besadenovec+ valacyclovir · 1 trial · 2 indications
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT) |
| Control | ACTIVE_COMPARATOR | External Beam Radiation Therapy (EBRT) alone |
| Name | Type | Description |
|---|---|---|
| aglatimagene besadenovec + valacyclovir | BIOLOGICAL | aglatimagene 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) | RADIATION | Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT) |
Inclusion Criteria: 1. 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) intermediate-risk criteria 4. Participants must be planning and medically...
Aglatimagene Besadenovec is an investigational gene therapy being studied for the treatment of non-squamous non-small cell lung cancer and prostate cancer. In prostate cancer, it is evaluated in patients treated by radiotherapy and in those undergoing active surveillance. It is also being tested in non-small cell lung cancer.
Aglatimagene Besadenovec is a gene therapy that belongs to the -vec/-gene target class. It is designed to deliver a gene to cancer cells, and it is administered together with the prodrug valacyclovir. The therapy is being studied to induce an immune response against tumors.
Aglatimagene Besadenovec is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical trials of this investigational gene therapy in oncology indications.
Aglatimagene Besadenovec is currently in Phase 3 clinical development. It has received Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designations from the FDA. The drug is investigational and has not been approved by the FDA.
Aglatimagene Besadenovec is being studied in several clinical trials. NCT01436968 is a Phase 3 trial in localized prostate cancer with radiation therapy. NCT02768363 is a Phase 2 trial in prostate cancer during active surveillance. NCT04495153 is a Phase 2 trial in non-small cell lung cancer. NCT07660094 is a Phase 3 trial in non-squamous non-small cell lung cancer.
Aglatimagene Besadenovec is also known as aglatimagene besadenovec plus valacyclovir. In clinical trials, it is referred to as CAN-2409, as seen in the trial titles for prostate cancer and non-small cell lung cancer studies.