MelanomaPhase 1/2NCT01397708
Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma
A Phase 1/2 study testing INXN-2001 and INXN-1001 in people with Melanoma, run by Alaunos Therapeutics at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- INXN-2001 and INXN-1001
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2011to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Fletcher Allen Health
Burlington, Vermont, 05401
Mary Crowley Cancer Research Center
Dallas, Texas, 75201
St. Lukes
Easton, Pennsylvania, 15232
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, 46526
The Angeles Clinic
Los Angeles, California, 90404
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Atlantic Melanoma Center
Morristown, New Jersey, 07960
Oncology Specialists
Park Ridge, Illinois, 60068
Washington University
St Louis, Missouri, 63110
About this study
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.
Read the 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 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.
- Conditions
- Melanoma
- Being tested
- INXN-2001, INXN-1001
- Keywords
- Melanoma, Unresectable
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INXN-2001Biological
Also called Ad-RTS-hIL-12
- approximately 1.0 x 1012 viral particles (vp) per injection
- one intratumoral injection of INXN-2001 per study cycle
- maximum of 6 study cycles
INXN-1001Drug
Also called Activator Ligand
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: INXN-2001; Drug: INXN-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) for INXN-1001, calculated during the first treatment cycle.
Measured: 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)
Progression-Free Survival (PFS) was defined as the time in days from the first dose of study treatment to the first assessment of disease progression or death from any cause, whichever occurred first. Subjects who withdrew from the study were censored at the date of their last non-progressive disease assessment. The final analysis was performed using Kaplan-Meier methodology to determine the median PFS.
Measured: 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)
Tumor biopsy samples were analyzed for IL-12 mRNA expression using quantitative real-time polymerase chain reaction (qRT-PCR).
Expression levels were normalized to the housekeeping gene ACTB (β-actin) and quantified using the ΔΔCt method.
For each participant, the median ΔΔCt-based fold-change from baseline to post-treatment was calculated.
These individual participant-level medians were then averaged to derive the mean of medians (measure type) across all participants within each arm/group.
The reported values therefore reflect the mean of medians in arbitrary units (AU), representing relative IL-12 mRNA expression normalized to ACTB- calculated as 2^(-ΔΔCt) fold-change relative to baseline
Not all subjects in each arm contributed evaluable IL-12 mRNA expression data due to biopsy availability and RNA quality.
Measured: 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
The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration, as determined from plasma sample analysis during the first treatment cycle
Measured: 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)
The percentage of Cytotoxic T-Lymphocytes (CTLs) within the CD8+ T-cell population was measured from serum samples by flow cytometry to assess changes in immune cell populations.
Measured: Baseline (Screening) and at Cycle 2, Day 7
Change From Baseline in Peripheral Blood Regulatory T-cells (Tregs)
The percentage of Regulatory T-cells (Tregs) in peripheral blood lymphocytes was measured from serum samples by flow cytometry to assess changes in immune cell populations.
Measured: Baseline (Screening) and at Cycle 2, Day 7.
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression
Tumor biopsy samples were analyzed for IFN-γ mRNA expression using quantitative real-time polymerase chain reaction (qRT-PCR). This measure reports the fold change in expression from baseline. Due to very low or undetectable baseline IFN-γ expression in many tumor biopsy samples, the fold change values calculated by qRT-PCR using the delta-delta Ct method may result in large numeric values. All values reported reflect fold change from baseline and were calculated per the qRT-PCR assay standard procedures
Measured: Baseline (Screening) and at the Post-Treatment Safety Assessment (28 days after the end of Cycle 1).
Ad-RTS-hIL-12 Vector Copy Numbers in Tumor Biopsy Samples
To evaluate the presence of the viral vector in the tumor, biopsy samples were assessed for vector copy numbers using a quantitative polymerase chain reaction (qPCR) assay. The results are reported as the number of vector copies per 100 nanograms (ng) of deoxyribonucleic acid (DNA).
Measured: Day 2 of Cycle 1, Day 2 of Cycle 2, and Day 2 of Cycle 3.
Best Overall Response (BOR) by RECIST 1.1 Criteria
Best Overall Response (BOR) was a pre-specified secondary endpoint assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BOR is the best response recorded from the start of treatment until disease progression. Responses include Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).
Measured: From the first dose of study treatment for up to 1 year.
Time to Maximum Plasma Concentration (Tmax) of INXN-1001 (Veledimex) in Cycle 1
The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration during the first treatment cycle.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaymes Holland, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397708
- Sponsor's protocol ID
- ADA1001
- Other IDs
- ATI001-101
- Status last verified
- Oct 2025
- First submitted
- 14 Jul 2011
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01397708
- Acronym / sponsor ID
- ADA1001
- Conditions
- Melanoma
- Keywords
- Melanoma, Unresectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INXN-1001 in combination with INXN-2001 | Experimental | Biological: INXN-2001, Drug: INXN-1001Intratumoral injections of INXN-2001 (Ad-RTS-hIL-12) at a constant dose in combination with inter-cohort escalating doses of INXN-1001 (activator ligand). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INXN-2001Also: Ad-RTS-hIL-12* approximately 1.0 x 1012 viral particles (vp) per injection * one intratumoral injection of INXN-2001 per study cycle * maximum of 6 study cycles | Biological | INXN-1001 in combination with INXN-2001 |
| INXN-1001Also: Activator Ligand* 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) | Drug | INXN-1001 in combination with INXN-2001 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From the signing of informed consent until 28 days after the last dose of study treatment, up to 28 weeks
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.
10 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) of INXN-1001 (Veledimex) in Cycle 1
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline (Screening) and at Cycle 2, Day 7
Change From Baseline in Peripheral Blood Regulatory T-cells (Tregs)
Time frame: Baseline (Screening) and at Cycle 2, Day 7.
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression
Time frame: Baseline (Screening) and at the Post-Treatment Safety Assessment (28 days after the end of Cycle 1).
Ad-RTS-hIL-12 Vector Copy Numbers in Tumor Biopsy Samples
Time frame: Day 2 of Cycle 1, Day 2 of Cycle 2, and Day 2 of Cycle 3.
Best Overall Response (BOR) by RECIST 1.1 Criteria
Time frame: From the first dose of study treatment for up to 1 year.
Time to Maximum Plasma Concentration (Tmax) of INXN-1001 (Veledimex) in Cycle 1
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaymes Holland study director
Alaunos Therapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INXN-2001 and INXN-1001 in people with Melanoma, run by Alaunos Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From the signing of informed consent until 28 days after the last dose of study treatment, up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.