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AdV-tk · 4 trials · 7 indications
National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be used for scoring toxicity and adverse events. The severity and frequency of toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportions of subjects who experienced grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: MGMT Unmethylated Patients | EXPERIMENTAL | After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8 and continues for 6 weeks. Temozolomide started after complete valacyclovir and stop when MGMT unmethylated result obtained. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression. |
| Cohort 2: MGMT Methylated & undetermined Patients | EXPERIMENTAL | After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8. Temozolomide started after complete valacyclovir and continue during radiation then 5 week break and then begin adjuvant temozolomide dosing. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression. |
| AdV-tk | EXPERIMENTAL | AdV-tk + valacyclovir in combination with standard of care radiation |
| A resectable | EXPERIMENTAL | Arm A is for resectable tumors. The first AdV-tk course is given prior to surgery by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery again followed by 14 days of valacyclovir. |
| B locally advanced | EXPERIMENTAL | Arm B is for locally advanced tumors for which chemoradiation is the planned standard of care treatment. AdV-tk is delivered by CT or EUS guided injection into the tumor. The first AdV-tk injection is given prior to starting chemoradiation and the second in week 3 of chemoradiation. Both injections are followed by 14 days of valacyclovir. Enrollment has been completed for Arm B. |
| A | EXPERIMENTAL | Arm A for unresectable malignant glioma was closed due to poor accrual. |
| B | EXPERIMENTAL | Arm B for resectable malignant glioma completed the Phase I accrual and long term follow up continues. A follow on study at dose level 3 was opened as a Phase 2a study (see BrTK02). |
| Name | Type | Description |
|---|---|---|
| AdV-tk | BIOLOGICAL | Given IT |
| Valacyclovir | DRUG | Given PO days 1-14; 1-3 days post surgery |
| Radiation | RADIATION | Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks |
| Temozolomide | DRUG | Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2) |
| Nivolumab | BIOLOGICAL | day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks |
| Laboratory Biomarker Analysis | OTHER | correlative studies |
Inclusion Criteria: * Patients must have operable brain tumor presumed to be high grade glioma (HGG) based on clinical and radiologic evaluation, where a gross total surgical resection of the contrast-enhancing area is intended; pathologic confirmation of HGG must be made at the time of surgery pri...
AdV-tk is an investigational gene therapy being studied for use in oncology, specifically for pancreatic adenocarcinoma, malignant pleural effusion, malignant glioma, and glioma. It has been evaluated in Phase 1 clinical trials for these conditions, including pediatric brain tumors and pancreatic cancer.
AdV-tk is being developed by Candel Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CADL.
AdV-tk is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for AdV-tk are Phase 1 studies.
AdV-tk has been studied in several completed Phase 1 trials, including NCT00634231 for pediatric brain tumors, NCT00638612 for pancreatic cancer, NCT01997190 for malignant pleural effusion, and NCT03576612 for high-grade gliomas.
AdV-tk is also known as GMCI, which stands for gene-mediated cytotoxic immunotherapy. In clinical trials, it has been referred to as GMCI when combined with other treatments like nivolumab and radiation therapy for gliomas.