Breast Cancer Nos Metastatic Recurrent
Conditions
Keywords
Genetically Modified Organism, Metastatic Breast Cancer, Recurrent Breast Cancer, Breast Cancer, Palifosfamide, INXN1001, INXN2001, Adenoviral vector
Brief summary
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.
Detailed description
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.
Interventions
GENETICAd-RTS-hIL-12 and Veledimex
Oral activator ligand with adenoviral vector injection of cancer lesions
DRUGPalifosfamide
Small molecule chemotherapy, IV administration
Sponsors
Alaunos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females ≥ 18 years of age 2. Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists. 3. 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). 4. Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia. 5. A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1. 6. Eastern Cooperative Oncology Group performance status 0, 1, 2 7. Male and female subjects must agree to use a highly reliable method of birth control. 8. Adequate bone marrow reserve as indicated by: 1. Absolute neutrophil count \> 1500/μL (without use of growth factors within 7 days) 2. Absolute lymphocyte count \> 700/μL (without use of growth factors within 7 days) 3. Platelet count \> 100,000/mm3 (without transfusion in prior 7 days) 4. Hemoglobin \> 9.0 g/dL (without transfusion in prior 7 days) 9. Estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation: eGFR ≥ 60 mL/min/1.73 m2 10. Adequate liver function as evidenced by the following: 1. Bilirubin ≤ 1.5 times the upper limits of normal (ULN) 2. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5×ULN, in the case of liver metastases ≤ 5×ULN
Exclusion criteria
1. 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) 2. Concomitant anticancer therapies 3. Prior therapies discontinuation periods: 1. Radiation within 3 weeks of enrollment 2. Chemotherapy within 4 weeks of enrollment 3. Nitrosoureas within 6 weeks of enrollment 4. Biologic therapy and/or immunomodulatory therapy, checkpoint inhibitors within 6 weeks of enrollment 5. No washout period is required for endocrine therapy 4. Radiation therapy encompassing \>25% of bone marrow 5. History of bone marrow or stem cell transplantation 6. Any congenital or acquired condition leading to inability to generate an immune response 7. Immunosuppressive therapy: 1. Systemic immunosuppressive drugs including corticosteroids (prednisone equivalent \>10 mg/day) 2. Immune suppression/requiring immunosuppressive drugs, including organ allografts 3. Active autoimmune disease requiring the equivalent of \>10 mg/day of prednisone 8. Major surgery within 4 weeks of study treatment 9. History of prior malignancy, unless the prior malignancy was diagnosed and definitively treated ≥5 years previously with no subsequent evidence of recurrence 10. 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. 11. Any medications that induce, inhibit, or are substrates of cytochrome P450 (CYP450) 3A4 within 7 days prior to the first dose of study drug 12. Subjects with meningeal carcinomatosis 13. Known significant hypersensitivity to study drugs or excipients 14. History of malabsorption syndrome or other condition that would interfere with enteral absorption 15. International Normalized Ratio (INR) and activated partial thromboplastin time \[PTT\] \<1.5 x ULN, if not therapeutically anticoagulated. 16. New York Heart Association (NYHA) Class II or greater congestive heart failure OR active ventricular arrhythmia requiring medication 17. Any other unstable or clinically significant concurrent medical condition 18. Localized infection at site of injectable lesion(s) requiring antiinfective therapy within 2 weeks of the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 16 months | 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-Week Progression-Free Survival (PFS) Rate | 16 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Cycle 1 Day 1 and Cycle 1 Day 7 | The area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) for INXN-1001 |
| Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | 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. | 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 |
| Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | 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. | Serum levels of IFN-γ were measured by immunoassay to assess the pharmacodynamic effect of the treatment |
| Change From Baseline in Serum Interleukin-12 (IL-12) Levels | 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. | Serum levels of IL-12 were measured by immunoassay to assess the pharmacodynamic effect of the treatment |
| Best Overall Response (BOR) by mRECIST v1.1 | 24 weeks | 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 |
| Change From Baseline in CD3+ CD8+ T-Cell Count | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 | Absolute counts of CD3+ CD8+ cytotoxic T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations |
| Maximum Plasma Concentration (Cmax) of INXN-1001 | 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 | The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration. |
| Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Cycle 1 Day 1 and Cycle 1 Day 7 | The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration |
| Clinical Benefit Rate (CBR) | From the first dose of study treatment for up to 1 year. | 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. |
| Change From Baseline in CD3+ CD4+ T-Cell Count | Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7 | Absolute counts of CD3+ CD4+ helper T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations. |
| Estimate PFS by Modified RECIST v1.1 | 16 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 4 |
| 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 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Clinically significant disease progression | 2 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Ad-RTS-hIL-12 + Veledimex 140 mg | Total | Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Ad-RTS-hIL-12 + Veledimex 100 mg Daily |
|---|---|---|---|---|
| Age, Continuous | 65.0 years | 62.5 years | 61.0 years | 58.0 years |
| BMI | 23.875 kg/m2 STANDARD_DEVIATION 4.7718 | 24.962 kg/m2 STANDARD_DEVIATION 4.6311 | 27.192 kg/m2 STANDARD_DEVIATION 0 | 26.306 kg/m2 STANDARD_DEVIATION 5.126 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 161.8 cm STANDARD_DEVIATION 8.72 | 161.3 cm STANDARD_DEVIATION 9.11 | 147.3 cm STANDARD_DEVIATION 0 | 163.8 cm STANDARD_DEVIATION 8.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Weight | 62.50 kg STANDARD_DEVIATION 13.498 | 65.09 kg STANDARD_DEVIATION 14.357 | 59.00 kg STANDARD_DEVIATION 0 | 71.15 kg STANDARD_DEVIATION 17.731 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 | 1 / 1 |
| other Total, other adverse events | 7 / 7 | 4 / 4 | 1 / 1 |
| serious Total, serious adverse events | 4 / 7 | 2 / 4 | 1 / 1 |
Outcome results
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
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | 16-Week Progression-Free Survival (PFS) Rate | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | 16-Week Progression-Free Survival (PFS) Rate | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | 16-Week Progression-Free Survival (PFS) Rate | 0 participants |
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.
Time frame: 16 months
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 3 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related Grade 3 or higher TEAE | 5 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Grade 3 or higher TEAE | 6 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 7 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to death | 0 participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related TEAE | 7 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Grade 3 or higher TEAE | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 4 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related TEAE | 4 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related Grade 3 or higher TEAE | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to death | 0 participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 2 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related Grade 3 or higher TEAE | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious TEAE | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Grade 3 or higher TEAE | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-related TEAE | 1 participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE leading to death | 1 participants |
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
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D1 | 8103 ng*h/mL | Standard Deviation 5200 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D7 | 19478 ng*h/mL | Standard Deviation 2353 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D1 | 89.0 ng*h/mL | Standard Deviation 36.1 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D7 | 250.1 ng*h/mL | Standard Deviation 101.4 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D7 | 193 ng*h/mL | Standard Deviation 74 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D1 | 5935 ng*h/mL | Standard Deviation 2660 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D1 | 105 ng*h/mL | Standard Deviation 16 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D7 | 10334 ng*h/mL | Standard Deviation 654 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D7 | 171 ng*h/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D7 | 8604 ng*h/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | Dose-normalized m2/mg AUC0-24 (ng*h/mL) at C1D1 | 266 ng*h/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001 | AUC0-24 (ng*h/mL) at C1D1 | 13350 ng*h/mL | Standard Deviation 0 |
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
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of stable disease (SD) | 2 Participants |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of unequivocal progression (UPD) | 2 Participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of stable disease (SD) | 1 Participants |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of unequivocal progression (UPD) | 2 Participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of stable disease (SD) | 0 Participants |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Best Overall Response (BOR) by mRECIST v1.1 | Best objective response of unequivocal progression (UPD) | 1 Participants |
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.
Time frame: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD4+ T-Cell Count | Follow-up Tumor Assessment: CD3+CD4+ (cell/mcL) | 367.33 cell/mcL | Standard Deviation 75.8 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD4+ T-Cell Count | Post-treatment Safety Assessment::CD3+ CD4+(cell/mcL) | 337.75 cell/mcL | Standard Deviation 155.513 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD4+ T-Cell Count | Screening: CD3+CD4+ (cell/mcL) | 845 cell/mcL | Standard Deviation 294.156 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD4+ T-Cell Count | Follow-up Tumor Assessment: CD3+CD4+ (cell/mcL) | 290 cell/mcL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD4+ T-Cell Count | Screening: CD3+CD4+ (cell/mcL) | 204.33 cell/mcL | Standard Deviation 82.59 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD4+ T-Cell Count | Post-treatment Safety Assessment::CD3+ CD4+(cell/mcL) | 218.00 cell/mcL | Standard Deviation 114.55 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in CD3+ CD4+ T-Cell Count | Screening: CD3+CD4+ (cell/mcL) | 263 cell/mcL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in CD3+ CD4+ T-Cell Count | Post-treatment Safety Assessment::CD3+ CD4+(cell/mcL) | 104 cell/mcL | Standard Deviation 0 |
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
Time frame: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD8+ T-Cell Count | Post-treatment Safety Assessment: CD3+CD8+ (cell/mcL) | 500.75 cell/mcL | Standard Deviation 594.91 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD8+ T-Cell Count | Screening: CD3+CD8+ (cell/mcL) | 1021 cell/mcL | Standard Deviation 702.86 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in CD3+ CD8+ T-Cell Count | Follow-up Tumor Assessment: CD3+CD8+ (cell/mcL) | 527.67 cell/mcL | Standard Deviation 441 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD8+ T-Cell Count | Follow-up Tumor Assessment: CD3+CD8+ (cell/mcL) | 150 cell/mcL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD8+ T-Cell Count | Screening: CD3+CD8+ (cell/mcL) | 168 cell/mcL | Standard Deviation 87.88 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in CD3+ CD8+ T-Cell Count | Post-treatment Safety Assessment: CD3+CD8+ (cell/mcL) | 252.5 cell/mcL | Standard Deviation 106.77 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in CD3+ CD8+ T-Cell Count | Post-treatment Safety Assessment: CD3+CD8+ (cell/mcL) | 159 cell/mcL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in CD3+ CD8+ T-Cell Count | Screening: CD3+CD8+ (cell/mcL) | 558 cell/mcL | Standard Deviation 0 |
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
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Screening: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 35.17 SFC/million PMBCs | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Post-treatment Safety Assessment: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 78.20 SFC/million PMBCs | Standard Deviation 75.16 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Screening: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 0 SFC/million PMBCs | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Post-treatment Safety Assessment: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 30 SFC/million PMBCs | Standard Deviation 42.43 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Screening: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 0 SFC/million PMBCs | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay | Post-treatment Safety Assessment: Granzyme B ELISPOT Muc-1 (SFC/million PMBCs) | 0 SFC/million PMBCs | Standard Deviation 0 |
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
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Peak level in C1: IFN-gamma (pg/mL) | 354.84 pg/mL | Standard Deviation 329.37 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Screening: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Post-treatment Safety Assessment: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Peak level in C1: IFN-gamma (pg/mL) | 309.4 pg/mL | Standard Deviation 358.37 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Screening: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Post-treatment Safety Assessment: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Screening: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Post-treatment Safety Assessment: IFN-gamma (pg/mL) | NA pg/mL | — |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels | Peak level in C1: IFN-gamma (pg/mL) | 68.1 pg/mL | Standard Deviation 0 |
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
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Peak level in C1:IL-12 (pg/mL) | 33.8 pg/mL | Standard Deviation 7.21 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Screening:Interleukin-12(pg/mL) | 0.513 pg/mL | Standard Deviation 0.409 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Post-treatment Safety Assessment:Interleukin-12 (pg/mL) | 0.81 pg/mL | Standard Deviation 0.854 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Peak level in C1:IL-12 (pg/mL) | 45.485 pg/mL | Standard Deviation 15.264 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Screening:Interleukin-12(pg/mL) | 0.485 pg/mL | Standard Deviation 0.341 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Post-treatment Safety Assessment:Interleukin-12 (pg/mL) | 1.38 pg/mL | Standard Deviation 1.67 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Screening:Interleukin-12(pg/mL) | 1.25 pg/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Post-treatment Safety Assessment:Interleukin-12 (pg/mL) | 2.1 pg/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Change From Baseline in Serum Interleukin-12 (IL-12) Levels | Peak level in C1:IL-12 (pg/mL) | 47.7 pg/mL | Standard Deviation 0 |
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.
Time frame: From the first dose of study treatment for up to 1 year.
Population: 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.
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.
Time frame: 16 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Estimate PFS by Modified RECIST v1.1 | 94 Days |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Estimate PFS by Modified RECIST v1.1 | 64 Days |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Estimate PFS by Modified RECIST v1.1 | 1 Days |
Secondary
Maximum Plasma Concentration (Cmax) of INXN-1001
The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration.
Time frame: 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
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D1 | 1024 ng/mL | Standard Deviation 705 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D7 | 1403 ng/mL | Standard Deviation 55 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D1 | 11.1 ng/mL | Standard Deviation 5.5 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D7 | 17.8 ng/mL | Standard Deviation 6.3 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24h (ng/mL) at C1D1 | 73.9 ng/mL | Standard Deviation 54 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24 (ng/mL) at C1D7 | 251 ng/mL | Standard Deviation 48.4 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24 (ng/mL) at C1D7 | 101 ng/mL | Standard Deviation 28 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D1 | 536 ng/mL | Standard Deviation 218 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D7 | 13 ng/mL | Standard Deviation 4 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24h (ng/mL) at C1D1 | 39.7 ng/mL | Standard Deviation 15.5 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D7 | 706 ng/mL | Standard Deviation 81 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D1 | 9.7 ng/mL | Standard Deviation 2.6 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D7 | 749 ng/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D1 | 22.5 ng/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24 (ng/mL) at C1D7 | 99 ng/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Dose-normalized m2/mg Cmax (ng/mL) at C1D7 | 14.9 ng/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | Cmax (ng/mL) at C1D1 | 1130 ng/mL | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Maximum Plasma Concentration (Cmax) of INXN-1001 | C24h (ng/mL) at C1D1 | 72 ng/mL | Standard Deviation 0 |
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
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad-RTS-hIL-12 + Veledimex 140 mg | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D1 | 3.7 hours | Standard Deviation 1.4 |
| Ad-RTS-hIL-12 + Veledimex 140 mg | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D7 | 3.3 hours | Standard Deviation 1.2 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D1 | 4.8 hours | Standard Deviation 2.5 |
| Ad-RTS-hIL-12 + Veledimex 100 mg Daily | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D7 | 3.0 hours | Standard Deviation 2 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D1 | 4 hours | Standard Deviation 0 |
| Ad-RTS-hIL-12 + Veledimex 80 mg Daily | Time to Maximum Plasma Concentration (Tmax) of INXN-1001 | Tmax (h) at C1D7 | 1 hours | Standard Deviation 0 |