Melanoma Clinical Trial
Official title:
A Phase I/II, Open Label Study of Ad-RTS-hIL-12, an Adenovirus Vector Engineered to Express hIL-12, in Combination With an Oral Activator Ligand, in Subjects With Unresectable Stage III or IV Melanoma
This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in
combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a
protein that may improve the body's natural response to disease by enhancing the ability of
the immune system to kill tumor cells and may interfere with blood flow to the tumor.
The main purpose of this study is to evaluate the safety and tolerability of tumor
injections of INXN-2001 given in combination with different doses of INXN-1001.
Single-arm, open label, Phase I/II dose escalation study of intratumoral injections
INXN-2001 and oral INXN-1001 in subjects with unresectable Stage III or IV melanoma.
Four sequential dose escalation cohorts of INXN-1001 in combination with a fixed dose of
INXN-2001 are planned. Subject enrollment and dose escalation will proceed according to a
standard 3+3 design.
Approximately 15 additional subjects will be enrolled as an expansion cohort at a single
dose level at or below the MTD.
- Safety and tolerability will be assessed by the incidence and severity of adverse
events.
- The antitumor activity of study treatment will be assessed according to RECIST v1.1
guidelines. Additional assessment of anti-tumor activity will be explored based on
total measurable tumor burden.
- Immunological and biological markers of response will include examinations of tumor
biopsy samples, cytokine levels, peripheral blood mononuclear cells (PBMC) and antibody
response to INXN-2001.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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