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Aglatimagene Besadenovec · 4 trials · 3 indications
To evaluate whether treatment with aglatimagene besadenovec (CAN-2409) plus valacyclovir and continued pembrolizumab improves overall survival (OS) compared to standard of care (SoC) docetaxel chemotherapy, in participants with Stage IV non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following prior pembrolizumab-based platinum chemoimmunotherapy
Tumor response as measured by RECIST criteria including overall response rate (ORR) and/or disease control rate (DCR)
Frequency of adverse events
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
| Arm | Type | Description |
|---|---|---|
| Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug | EXPERIMENTAL | Patients continue to receive pembrolizumab with two courses of Aglatimagene besadenovec plus valacyclovir |
| Arm 2: Docetaxel | ACTIVE_COMPARATOR | Patients receive standard of care docetaxel |
| ProstAtak® | EXPERIMENTAL | Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT |
| Control | PLACEBO_COMPARATOR | Placebo + valacyclovir + radiation therapy +/- ADT |
| Cohorts | OTHER | Cohort 1A and 1B - persistent but stable disease at least 18 weeks after starting ICI treatment Cohort 2A and 2B - radiographic progressive disease at least 18 weeks after starting ICI treatment Cohort 3 - refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment (CLOSED TO ENROLLMENT) |
| CAN-2409 | ACTIVE_COMPARATOR | Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
| Placebo | PLACEBO_COMPARATOR | Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
| Name | Type | Description |
|---|---|---|
| Aglatimagene Besadenovec | BIOLOGICAL | via intratumoral injections into lung or lymph nodes at two timepoints |
| Valacyclovir | DRUG | Oral, for14 days following each aglatimagene besadenovec injection |
| Pembrolizumab | BIOLOGICAL | every 3 weeks (Q3W) or every 6 weeks (Q6W) |
| Docetaxel | DRUG | every 21 days with standard premedication |
| Aglatimagene besadenovec + valacyclovir | BIOLOGICAL | Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| Placebo + valacyclovir | BIOLOGICAL | Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| placebo | BIOLOGICAL | Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
Inclusion Criteria: 1. Age ≥ 18 years, at the time of signing the informed consent. 2. Histologically confirmed metastatic Stage IV non-squamous NSCLC. 3. Measurable disease per RECIST v1.1 with at least 1 thoracic lesion amenable to intratumoral injection (e.g., pathological lymph node or lung les...
Aglatimagene Besadenovec is an investigational gene therapy being studied for non-squamous non-small cell lung cancer and prostate cancer, including prostate cancer patients treated by radiotherapy. It is in Phase 3 clinical development for non-squamous NSCLC and has received FDA Fast Track, RMAT, and Orphan Drug designations.
Aglatimagene Besadenovec is a gene therapy that works by delivering a gene to cancer cells. Its target class is -vec/-gene (gene tx), meaning it uses a viral vector to introduce genetic material into tumor cells to trigger an immune response against the cancer.
Aglatimagene Besadenovec is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CADL. The company is conducting clinical trials of this investigational gene therapy in oncology indications.
Aglatimagene Besadenovec is in Phase 3 clinical development. The Phase 3 trial, NCT07660094, is recruiting patients with stage IV non-squamous NSCLC. It is also being studied in Phase 2 trials for prostate cancer and earlier-stage NSCLC. It is not yet FDA approved.
Aglatimagene Besadenovec is being studied in four clinical trials. NCT07660094 is a Phase 3 trial in non-squamous NSCLC. NCT02768363 and NCT07332000 are Phase 2 trials in prostate cancer. NCT04495153 is a Phase 2 trial in NSCLC. All trials are active, with total enrollment of 898 patients.
Aglatimagene Besadenovec is also known as aglatimagene besadenovec plus valacyclovir, and it is referred to as CAN-2409 in clinical trial titles. The trials NCT02768363 and NCT04495153 use the name CAN-2409 for this same investigational gene therapy.