Status:
COMPLETED
Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 i...
Detailed Description
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 escalatio...
Eligibility Criteria
Inclusion
- 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 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01397708
Start Date
August 1 2011
End Date
September 1 2014
Last Update
October 29 2025
Active Locations (9)
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1
The Angeles Clinic
Los Angeles, California, United States, 90404
2
Oncology Specialists
Park Ridge, Illinois, United States, 60068
3
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
4
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202