Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ad-RTS-hIL-12
INXN-2001 · 4 trials · 4 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.
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). |
| INXN-1001 in combination with INXN-2001 | EXPERIMENTAL | Intratumoral injections of INXN-2001 (Ad-RTS-hIL-12) at a constant dose in combination with inter-cohort escalating doses of INXN-1001 (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 |
| INXN-2001 | BIOLOGICAL | * approximately 1.0 x 1012 viral particles (vp) per injection * one intratumoral injection of INXN-2001 per study cycle * maximum of 6 study cycles |
| INXN-1001 | DRUG | * 4 dose cohorts (5mg/day, 20mg/day, 100mg/day, and 160mg/day) * 7 oral daily doses of INXN-1001 per study cycle * maximum of 6 study cycles * 1 Expansion cohort at a single dose level at or below MTD (160mg/day) |
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 ...
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INXN-2001 is an investigational monoclonal antibody being developed for the treatment of melanoma. It is currently in Phase 1 clinical development and has been studied in a completed clinical trial in the United States.
INXN-2001 is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TCRT. The company is conducting clinical research on this investigational therapy for melanoma.
INXN-2001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial for this therapy has been completed.
INXN-2001 has been studied in one completed Phase 1 clinical trial, identified as NCT01397708. This trial was a safety study of an adenovirus vector engineered to express hIL-12 in combination with an activator ligand for the treatment of melanoma.
The completed Phase 1 clinical trial of INXN-2001, NCT01397708, enrolled 26 patients with melanoma. The trial was conducted in the United States and included adults aged 18 years and older.