Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma

NCT01397708 | Completed Phase 1 Results

• 2 other identifiers: ADA1001ATI001-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 9

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 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.

Conditions

Melanoma

Keywords

Melanoma; Unresectable

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events

  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.

  From the signing of informed consent until 28 days after the last dose of study treatment, up to 28 weeks

Secondary Outcomes (10)

• Area Under the Plasma Concentration-Time Curve (AUC) of INXN-1001 (Veledimex) in Cycle 1

  Samples were collected in Cycle 1 on Day 1 (pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose), Day 2 (pre-dose), Day 7 (pre-dose and 1-2 and 4-6 hours post-dose), and Day 8 (24 hours after the Day 7 dose).

• Progression-Free Survival (PFS)

  From the first dose of study treatment for up to 1 year.

• Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units)

  Baseline (Screening) and at the Post-Treatment Safety Assessment (approximately 28 days after the end of Cycle 1).

• Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1

  Samples were collected in Cycle 1 on Day 1 (pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose), Day 2 (pre-dose), Day 7 (pre-dose and 1-2 and 4-6 hours post-dose), and Day 8 (24 hours after the Day 7 dose)

• Change From Baseline in Peripheral Blood Cytotoxic T-Lymphocytes (CTLs)

  Baseline (Screening) and at Cycle 2, Day 7

Study Arms (1)

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).

Biological: INXN-2001; Drug: INXN-1001

Interventions

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

Also known as: Ad-RTS-hIL-12

INXN-1001 in combination with INXN-2001

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)

Also known as: Activator Ligand

INXN-1001 in combination with INXN-2001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (9)

The Angeles Clinic

Los Angeles, California, 90404, United States

Location

Oncology Specialists

Park Ridge, Illinois, 60068, United States

Location

Indiana University Health Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Atlantic Melanoma Center

Morristown, New Jersey, 07960, United States

Location

St. Lukes

Easton, Pennsylvania, 15232, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75201, United States

Location

Fletcher Allen Health

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jaymes Holland Clinical Consultant
• Organization: Alaunos Therapeutics, Inc

jholland@alaunos.com

6502732627

Study Officials

• Jaymes Holland

  Alaunos Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 19, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Locations

US (9)