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CAN-2409 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Single arm | EXPERIMENTAL | This study is an extension of evaluation of the surgical resection arm, Arm B, from a phase Ib study in which dose escalation on arm B was completed. |
| Name | Type | Description |
|---|---|---|
| CAN-2409 | BIOLOGICAL | Single dose of 3x10e11 vector particles of CAN-2409 delivered to the tumor bed after resection on day 0. |
| Valacyclovir | DRUG | Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3 |
| Temozolomide | DRUG | Concomitant TMZ will be administered orally once a day at a dose of 75 mg/m2 starting the next day after completing prodrug and continued for 6 weeks. Adjuvant TMZ will be administered days 1 to 5 of a 28-day cycle for 6 cycles with 150 mg/m2 administered for cycle 1, and 150 to 200 mg/m2 administered for cycles 2 to 6. Adjuvant treatment will start 1 month following completing RT. |
| Radiation therapy | RADIATION | Radiation will be administered to up-front patients as per standard of care for the patient. It will start 3-7 days after CAN-2409 injection, preferably closer to 3 days. It will consist of standard external field radiation, limited to the area of tumor and brain adjacent to tumor, fractionated at doses of 200cGy per day for approximately 6 weeks to a total of 5500-6000 cGy. |
Inclusion Criteria: * Patients must have presumed resectable or partially resectable malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined). Patients who have previously received CAN...
CAN-2409 is an investigational oncology therapy being studied for malignant glioma and lung cancer. In malignant glioma, it has been evaluated in a Phase 2a study combined with standard radiation therapy for conditions including glioblastoma multiforme, anaplastic astrocytoma, and high grade glioma. It has also been studied in patients with resectable non-small cell lung cancer.
CAN-2409 is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical research on this investigational therapy for oncology indications.
CAN-2409 is in Phase 2 clinical development. A Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma has been completed. An additional Phase 1 study in resectable non-small cell lung cancer has also been completed. The drug is investigational and not yet approved.
CAN-2409 has been studied in two completed clinical trials. NCT00589875 was a Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma, enrolling 52 participants in the United States. NCT03131037 was a Phase 1 study of intratumoral gene mediated cytotoxic immunotherapy in patients with resectable non-small cell lung cancer, enrolling 12 participants.
CAN-2409 has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration. These designations are intended to facilitate development and review of therapies for serious conditions.
CAN-2409 is not being studied with a biomarker-selected patient population in its clinical trials. The completed trials enrolled patients based on their cancer diagnosis rather than on specific molecular biomarkers.