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Ad-RTS-hIL-12 · 3 trials · 3 indications
Evaluation of adverse events as assessed by CTCAE v4.03. Adverse events will be summarized based on the incidence, intensity and type of adverse event.
The Day 0 (as applicable), and Day 1 doses of veledimex were administered by study personnel at the study center. Thereafter, subjects could self-administer the remaining once daily dose of veledimex. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time the subject ate the last meal prior to administration of veledimex, the number of capsules taken, whether the subject missed any veledimex doses, and reason for any missed doses. Investigational product container(s) with any remaining capsules were returned to the study staff on Day 15, and staff assessed dose compliance.
Evaluation of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 will be based on the incidence, intensity and type of adverse event. AEs will be regarded as treatment-emergent adverse events (TEAEs) during the treatment period regardless of relationship to study drug if: • The AE occurred or worsened from baseline during or after administration of the first dose of study drug (on or after Day 0).
Evaluation will be based on expected dose compliance. Subjects were instructed to document veledimex dosing compliance in a subject diary, including the time each dose was taken, the time of the last meal prior to administration of veledimex, the number of capsules taken, whether the subject missed any veledimex doses, and reason for any missed doses. Investigational product container(s) with any remaining capsules were returned to the study staff on Day 15, and staff assessed dose compliance.
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs). Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
| Arm | Type | Description |
|---|---|---|
| Ad-RTS-hIL-12 + veledimex | EXPERIMENTAL | Intratumoral Ad-RTS-hIL-12 and oral veledimex |
| Ad-RTS-hIL-12 + veledimex in combination with nivolumab | EXPERIMENTAL | Intratumoral Ad-RTS-hIL-12 and varying doses of oral veledimex (activator ligand) given in combination with nivolumab via infusion. |
| Ad-RTS-hIL-12+veledimex | EXPERIMENTAL | varying doses of intratumoral Ad-RTS-hIL-12 (INXN-2001) and oral veledimex (activator ligand). |
| Name | Type | Description |
|---|---|---|
| Ad-RTS-hIL-12 | BIOLOGICAL | * 2.0 x 10\^11 viral particles (vp) per injection * intratumoral injection of Ad-RTS-hIL-12 |
| veledimex | DRUG | * 20mg/day * 15 oral daily doses of veledimex |
| Nivolumab | DRUG | * 2 doses (1mg/kg, 3mg/kg) * Every 2 weeks |
Inclusion Criteria: * Male or female subject ≥18 and ≤75 years of age * Provision of written informed consent for tumor resection, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures * Histologically confirmed glioblastoma ...
Ad-RTS-hIL-12 is an investigational therapy being studied for the treatment of glioblastoma multiforme and glioblastoma. It is being developed by Alaunos Therapeutics, Inc. (TCRT) and is currently in Phase 1 clinical development. The drug is administered with veledimex and has been evaluated in completed trials.
Ad-RTS-hIL-12 is designed to deliver interleukin-12 (IL-12) to the tumor microenvironment. It is a gene therapy approach that uses an adenoviral vector to express IL-12 under the control of an oral activator, veledimex. This allows for regulated production of IL-12, which stimulates an anti-tumor immune response.
Ad-RTS-hIL-12 is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TCRT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma.
Ad-RTS-hIL-12 is in Phase 1 clinical development. All three clinical trials listed for the drug are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities for any indication.
Ad-RTS-hIL-12 has been studied in three completed Phase 1 trials: NCT02026271, which enrolled 40 patients with glioblastoma or malignant glioma; NCT03636477, which evaluated the drug in combination with nivolumab in 21 glioblastoma patients; and NCT03679754, which assessed the drug in 36 patients with recurrent or progressive glioblastoma.
No, Ad-RTS-hIL-12 is not the same as veledimex. Ad-RTS-hIL-12 is the investigational gene therapy that encodes for interleukin-12, while veledimex is an oral activator drug used to control the expression of IL-12 from Ad-RTS-hIL-12. They are used together in clinical trials.