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After SRC review and Sponsor's halting palifosfamide development, data was collected for Part 1, Arm A. Doses of 80, 100, and 140 mg were used. The SRC reduced 140 mg to 100 mg, then to 80 mg. The study ended with one subject enrolled at 80 mg daily.
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Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions.
Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.
Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide.
Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy.
Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C.
Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin.
Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ad-RTS-hIL-12 and veledimex | Experimental | Experimental study drug monotherapy arm (A) |
|
| Ad-RTS-hIL-12 and Palifosfamide | Experimental | Study drug combination therapy arm (C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad-RTS-hIL-12 and Veledimex | Genetic | Oral activator ligand with adenoviral vector injection of cancer lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations. | 16 months |
| 16-Week Progression-Free Survival (PFS) Rate | This is the primary efficacy endpoint, defined as the proportion of subjects who had not progressed or died prior to 16 weeks from the date of their first dose. Progression was determined by modified Response Evaluation Criteria in Solid Tumors | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) by mRECIST v1.1 | Best Overall Response (BOR) was determined for each evaluable subject up to their final tumor assessment. Per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1, responses were defined as: Complete Response (CR), disappearance of all non-nodal target lesions and reduction in short axis of pathological lymph nodes to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% increase in the sum of diameters from the smallest sum recorded; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD |
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Inclusion criteria:
Males or females ≥ 18 years of age
Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists.
Failed or progressed on at least 1 prior systemic chemotherapy regimen ± biologic/experimental therapy (if first-line therapy, failure or progression during the first 30 days).
Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1.
Eastern Cooperative Oncology Group performance status 0, 1, 2
Male and female subjects must agree to use a highly reliable method of birth control.
Adequate bone marrow reserve as indicated by:
Estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation: eGFR ≥ 60 mL/min/1.73 m2
Adequate liver function as evidenced by the following:
Exclusion Criteria:
Subjects with human epidermal growth factor receptor 2 (HER2)/neu-positive (immunohistochemistry [IHC]) 3+ or fluorescence in situ hybridization-amplified) breast tumors who are eligible for, but who have not received HER2-targeted therapy (eg, trastuzumab)
Concomitant anticancer therapies
Prior therapies discontinuation periods:
Radiation therapy encompassing >25% of bone marrow
History of bone marrow or stem cell transplantation
Any congenital or acquired condition leading to inability to generate an immune response
Immunosuppressive therapy:
Major surgery within 4 weeks of study treatment
History of prior malignancy, unless the prior malignancy was diagnosed and definitively treated ≥5 years previously with no subsequent evidence of recurrence
Subjects with brain or subdural metastases, unless local therapy has completed and corticosteroids have been discontinued for this indication for ≥4 weeks before starting study treatment.
Any medications that induce, inhibit, or are substrates of cytochrome P450 (CYP450) 3A4 within 7 days prior to the first dose of study drug
Subjects with meningeal carcinomatosis
Known significant hypersensitivity to study drugs or excipients
History of malabsorption syndrome or other condition that would interfere with enteral absorption
International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] <1.5 x ULN, if not therapeutically anticoagulated.
New York Heart Association (NYHA) Class II or greater congestive heart failure OR active ventricular arrhythmia requiring medication
Any other unstable or clinically significant concurrent medical condition
Localized infection at site of injectable lesion(s) requiring antiinfective therapy within 2 weeks of the first dose of study drug.
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| Name | Affiliation | Role |
|---|---|---|
| Jaymes Holland | Alaunos Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States | ||
| Henry Ford Health System |
Following the decision by the SRC the study will only collect data for the part 1, arm A group. Three dose level cohorts (140 mg, 100 mg, 80 mg) for INXN-1001 are used instead of the original single INXN-1001 dose level.
Summaries that were based on part and treatment arm will instead be by dosage level of INXN-1001 where appropriate, with an overall group containing data from all dosage levels.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ad-RTS-hIL-12 + Veledimex 140 mg | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle |
| FG001 | Ad-RTS-hIL-12 + Veledimex 100 mg Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2013 | Jul 19, 2025 |
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|
| Palifosfamide | Drug | Small molecule chemotherapy, IV administration |
|
|
| 24 weeks |
| Estimate PFS by Modified RECIST v1.1 | Progression-free survival (PFS) is the time in days from the first dose of study treatment to the first assessment on which the response is reported as disease progression or death due to any cause (whichever is first) + 1 day. Subjects withdrawing from the study will be censored at their last non-progressive disease response assessment. If a subject does not have a disease response assessment, the subject will be censored on the date of the first treatment as described above. Kaplan-Meier plots will not be presented; PFS will be listed only. | 16 months |
| Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | The area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) for INXN-1001 | Cycle 1 Day 1 and Cycle 1 Day 7 |
| Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | To assess for a cellular immune response, the number of MUC-1 specific interferon-gamma (IFN-γ) secreting T-cells was measured from peripheral blood mononuclear cells (PBMCs) using an ELISPOT assay. Results are reported as spot-forming cells (SFC) per million PBMCs | Screening and the Post-Treatment Safety Assessment visit (28 days after the last dose of study drug), with the final assessment occurring up to 7 months after the start of treatment. |
| Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Serum levels of IFN-γ were measured by immunoassay to assess the pharmacodynamic effect of the treatment | Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment. |
| Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Serum levels of IL-12 were measured by immunoassay to assess the pharmacodynamic effect of the treatment | Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment. |
| Change From Baseline in CD3+ CD4+ T-Cell Count | Absolute counts of CD3+ CD4+ helper T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations. | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 |
| Change From Baseline in CD3+ CD8+ T-Cell Count | Absolute counts of CD3+ CD8+ cytotoxic T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 |
| Maximum Plasma Concentration (Cmax) of INXN-1001 | The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration. | Cycle 1 Day 1 and Cycle 1 Day 7. On Day 1, samples were collected pre-dose and at 0.5, 1, 2, 4, and 6 hours post-dose. On Day 7, samples were collected pre-dose and at 1-2 and 4-6 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration | Cycle 1 Day 1 and Cycle 1 Day 7 |
| Clinical Benefit Rate (CBR) | Clinical Benefit Rate (CBR) was a pre-specified secondary endpoint defined as the proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by modified RECIST (mRECIST) v1.1. | From the first dose of study treatment for up to 1 year. |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| The Jones Clinic, PC | Germantown | Tennessee | 38138 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75201 | United States |
| Evergreen Hematology & Oncology | Spokane | Washington | 99218 | United States |
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
| FG002 | Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle |
| COMPLETED | Completed 6 cycles of treatment |
|
| NOT COMPLETED |
|
|
The Safety population is defined as all subjects who receive at least one dose of study treatment (veledemix capsule and/or an injection of Ad-RTS-hIL-12).
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| ID | Title | Description |
|---|---|---|
| BG000 | Ad-RTS-hIL-12 + Veledimex 140 mg | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle |
| BG001 | Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle |
| BG002 | Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations. | The Safety population is defined as all subjects who receive at least one dose of study treatment (veledemix capsule and/or an injection of Ad-RTS-hIL-12). | Posted | Number | participants | 16 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 16-Week Progression-Free Survival (PFS) Rate | This is the primary efficacy endpoint, defined as the proportion of subjects who had not progressed or died prior to 16 weeks from the date of their first dose. Progression was determined by modified Response Evaluation Criteria in Solid Tumors | Posted | Number | participants | 16 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) by mRECIST v1.1 | Best Overall Response (BOR) was determined for each evaluable subject up to their final tumor assessment. Per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1, responses were defined as: Complete Response (CR), disappearance of all non-nodal target lesions and reduction in short axis of pathological lymph nodes to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% increase in the sum of diameters from the smallest sum recorded; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | The Efficacy Evaluable population is defined as all subjects who receive at least one dose of study treatment (veledimex capsule and/or an injection of Ad-RTS-hIL-12) and have at least one post-screening mRECIST response evaluation. | Posted | Count of Participants | Participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Estimate PFS by Modified RECIST v1.1 | Progression-free survival (PFS) is the time in days from the first dose of study treatment to the first assessment on which the response is reported as disease progression or death due to any cause (whichever is first) + 1 day. Subjects withdrawing from the study will be censored at their last non-progressive disease response assessment. If a subject does not have a disease response assessment, the subject will be censored on the date of the first treatment as described above. Kaplan-Meier plots will not be presented; PFS will be listed only. | The Efficacy Evaluable population is defined as all subjects who receive at least one dose of study treatment (veledimex capsule and/or an injection of Ad-RTS-hIL-12) and have at least one post-screening mRECIST response evaluation. | Posted | Median | Full Range | Days | 16 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | The area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) for INXN-1001 | The PK population includes all subjects in the Safety Run-in (Part 1) who had sufficient plasma concentration data to derive the specified parameter. The number of participants analyzed may be less than the total number in the arm due to missed PK sample collections or samples of insufficient quality for analysis | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day 1 and Cycle 1 Day 7 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | To assess for a cellular immune response, the number of MUC-1 specific interferon-gamma (IFN-γ) secreting T-cells was measured from peripheral blood mononuclear cells (PBMCs) using an ELISPOT assay. Results are reported as spot-forming cells (SFC) per million PBMCs | The Efficacy Evaluable population included all subjects who received at least one dose of study treatment and had at least one post-screening mRECIST response evaluation. The number of participants analyzed for this specific biomarker may be less than the total number in the arm due to missed sample collections or samples of insufficient quality for analysis. | Posted | Mean | Standard Deviation | SFC/million PMBCs | Screening and the Post-Treatment Safety Assessment visit (28 days after the last dose of study drug), with the final assessment occurring up to 7 months after the start of treatment. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Serum levels of IFN-γ were measured by immunoassay to assess the pharmacodynamic effect of the treatment | The Efficacy Evaluable population included all subjects who received at least one dose of study treatment and had at least one post-screening mRECIST response evaluation. The number of participants analyzed for this specific biomarker may be less than the total number in the arm due to missed sample collections or samples of insufficient quality for analysis. | Posted | Mean | Standard Deviation | pg/mL | Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Serum levels of IL-12 were measured by immunoassay to assess the pharmacodynamic effect of the treatment | The Efficacy Evaluable population included all subjects who received at least one dose of study treatment and had at least one post-screening mRECIST response evaluation. The number of participants analyzed for this specific biomarker may be less than the total number in the arm due to missed sample collections or samples of insufficient quality for analysis. | Posted | Mean | Standard Deviation | pg/mL | Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD3+ CD4+ T-Cell Count | Absolute counts of CD3+ CD4+ helper T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations. | The Efficacy Evaluable population included all subjects who received at least one dose of study treatment and had at least one post-screening mRECIST response evaluation. The number of participants analyzed for this specific biomarker may be less than the total number in the arm due to missed sample collections or samples of insufficient quality for analysis. | Posted | Mean | Standard Deviation | cell/mcL | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD3+ CD8+ T-Cell Count | Absolute counts of CD3+ CD8+ cytotoxic T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations | The Efficacy Evaluable population included all subjects who received at least one dose of study treatment and had at least one post-screening mRECIST response evaluation. The number of participants analyzed for this specific biomarker may be less than the total number in the arm due to missed sample collections or samples of insufficient quality for analysis. | Posted | Mean | Standard Deviation | cell/mcL | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of INXN-1001 | The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration. | The PK population includes all subjects in the Safety Run-in (Part 1) who had sufficient plasma concentration data to derive the specified parameter. The number of participants analyzed may be less than the total number in the arm due to missed PK sample collections or samples of insufficient quality for analysis | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 1 and Cycle 1 Day 7. On Day 1, samples were collected pre-dose and at 0.5, 1, 2, 4, and 6 hours post-dose. On Day 7, samples were collected pre-dose and at 1-2 and 4-6 hours post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration | The PK population includes all subjects in the Safety Run-in (Part 1) who had sufficient plasma concentration data to derive the specified parameter. The number of participants analyzed may be less than the total number in the arm due to missed PK sample collections or samples of insufficient quality for analysis | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 1 and Cycle 1 Day 7 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | Clinical Benefit Rate (CBR) was a pre-specified secondary endpoint defined as the proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by modified RECIST (mRECIST) v1.1. | The protocol pre-specified that the Clinical Benefit Rate (CBR) would be calculated. However, the final Statistical Analysis Plan states that due to the study's early termination and small sample size, this rate was not calculated. Best Overall Response for each individual subject was determined and is reported in a separate outcome measure. | Posted | From the first dose of study treatment for up to 1 year. |
|
16 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ad-RTS-hIL-12 + Veledimex 140 mg | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle | 0 | 7 | 4 | 7 | 7 | 7 |
| EG001 | Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle | 0 | 4 | 2 | 4 | 4 | 4 |
| EG002 | Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle | 1 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v17 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v17 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v17 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v17 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v17 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Asthena | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Oedema mucosal | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 17 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Blood urea decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 17 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Mylagia | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 17 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 17 | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA 17 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 17 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaymes Holland | Alaunos Therapeutics | 6502732627 | jholland@alaunos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2015 | Mar 23, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626304 | veledimex |
| C027061 | isophosphamide mustard |
| D000069455 | Palivizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Grade 3 or higher TEAE |
|
| Treatment-related Grade 3 or higher TEAE |
|
| TEAE leading to death |
|
| Serious TEAE |
|
| TEAE leading to discontinuation |
|
|
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily |
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle |
|
|
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|