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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Unresectable Stage III or IV Melanoma

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Trial Information

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.

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

- A minimum of 2 accessible nonvisceral lesions (shortest diameter ≥1 cm) or palpable
tumor-involved lymph nodes (shortest diameter ≥1.5 cm).

- ECOG performance status of 0 or 1 (Appendix 1).

- Adequate bone marrow, liver, and renal function.

- An expected survival of at least approximately 6 months.

- Male and female subjects must agree to use a highly reliable method of birth control
(expected failure rate less than 5% per year) from the screening visit through 28
days after the last dose of study drug.

Exclusion Criteria:

- Any prior anti-cancer therapy or investigational agent within 28 days prior to the
first dose of study drug. (NOTE: For the expansion cohort ONLY, if subjects received
ipilimumab, a 90-day washout period since last dose of ipilimumab is required. If
subjects received other immunomodulating therapies (eg, anti-PD1 antibodies), the
medical monitor should be contacted and an evaluation will be made.)

- Clinically significant infection requiring systemic antibacterial, antifungal, or
antiviral therapy within 2 weeks of the first dose of study drug.

- History of HIV infection.

- Active autoimmune disease requiring steroids (>10 mg prednisone or comparable) or
other immunosuppressive therapy (e.g., methotrexate, etc.).

- Documented symptomatic brain metastases. Screening for brain lesions by CT or MRI is
not required for all potential subjects; however, if there are any neurological signs
or symptoms consistent with brain metastases, then a brain CT or MRI should be
performed as clinically indicated.

- Any medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days
prior to the first dose of study drug.

- Prior history of hematopoietic stem cell transplant or organ allograft.

- Other concurrent clinically active malignant disease, with the exception of other
cancers of the skin.

- Females who are nursing or pregnant.

- Subjects who have a history of hypersensitivity that may relate to any component of
the study drugs, e.g. to benzoic acid since INXN-1001 contains two benzene rings.

- Unstable or clinically significant concurrent medical condition that would, in the
opinion of the investigator, jeopardize the safety of a subject and/or their
compliance with the protocol.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Unresectable Stage III or IV Melanoma
  • Melanoma
  • Unresectable
  • Melanoma



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