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Also known as CAN-2409
CAN-2409+ valacyclovir · 2 trials · 5 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. |
| Study Arm | EXPERIMENTAL | CAN-2409 + valacyclovir |
| 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. |
| CAN-2409 + valacyclovir | BIOLOGICAL | CAN-2409 will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each injection. |
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 plus valacyclovir is an investigational gene therapy combination being studied in oncology. CAN-2409 is given intratumorally alongside valacyclovir, an oral antiviral used as part of the treatment regimen. Candel Therapeutics, Inc. (ticker CADL) is developing it for lung cancer and malignant glioma, including glioblastoma multiforme and anaplastic astrocytoma.
CAN-2409 plus valacyclovir has been studied in resectable non-small cell lung cancer. A completed Phase 1 trial, NCT03131037, evaluated intratumoral gene mediated cytotoxic immunotherapy in patients with resectable non-small cell lung cancer in the United States and enrolled 12 participants. The program is investigational and has not been approved for use.
Candel Therapeutics, Inc., which trades under the ticker CADL, is the developer of CAN-2409 plus valacyclovir. The company is advancing the agent as an investigational gene therapy in oncology, with clinical work in lung cancer and malignant glioma.
CAN-2409 plus valacyclovir has been tested in Phase 1 and Phase 2a clinical studies, and it remains investigational. The Phase 1 trial NCT03131037 in resectable non-small cell lung cancer is completed, and the Phase 2a trial NCT00589875 in malignant glioma is also completed. It has received a FAST_TRACK designation from the FDA.
Two completed trials have evaluated CAN-2409 plus valacyclovir. NCT03131037 was a Phase 1 study of intratumoral gene mediated cytotoxic immunotherapy in patients with resectable non-small cell lung cancer, enrolling 12 participants. NCT00589875 was a Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma, glioblastoma multiforme, anaplastic astrocytoma, and high grade glioma, enrolling 52 participants.
Yes. CAN-2409 plus valacyclovir and CAN-2409 refer to the same investigational agent from Candel Therapeutics. The combined name reflects that CAN-2409 is administered together with valacyclovir as part of the treatment regimen, while CAN-2409 alone is the shorthand used for the gene therapy component.