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INXN-2001 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Males or females of all races ≥ 18 years of age, who have provided written informed consent prior to completing any study specific procedure. * Unresectable Stage III or Stage IV melanoma arising from any site other than ocular melanoma. * A minimum of 2 accessible nonvisceral...
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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.