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
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
- 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
Evaluate the safety and tolerability of 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) in subjects with unresectable Stage III or IV melanoma.
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.
United States: Food and Drug Administration
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Oncology Specialists||Park Ridge, Illinois 60068|
|The Angeles Clinic||Santa Monica, California 90404|
|Washington University in St. Louis||St. Louis, Missouri 63110|
|Mary Crowley Cancer Research Center||Dallas, Texas 75246|
|Atlantic Melanoma Center||Morristown, New Jersey 07960|
|Indiana University Health Goshen Center For Cancer Care||Goshen, Indiana 46526|
|Indiana University - Simon Cancer Center||Indianapolis, Indiana 46202|
|Fletcher Allen Health Care, Inc.||Burlington, Vermont 05401|