Trial Outcomes & Findings for Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer. (NCT NCT01703754)
NCT ID: NCT01703754
Last Updated: 2025-08-28
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-08-28
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Clinically significant disease progression
|
2
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.
Baseline characteristics by cohort
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
58.0 years
n=7 Participants
|
61.0 years
n=5 Participants
|
62.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Height
|
161.8 cm
STANDARD_DEVIATION 8.72 • n=5 Participants
|
163.8 cm
STANDARD_DEVIATION 8.84 • n=7 Participants
|
147.3 cm
STANDARD_DEVIATION 0 • n=5 Participants
|
161.3 cm
STANDARD_DEVIATION 9.11 • n=4 Participants
|
|
Weight
|
62.50 kg
STANDARD_DEVIATION 13.498 • n=5 Participants
|
71.15 kg
STANDARD_DEVIATION 17.731 • n=7 Participants
|
59.00 kg
STANDARD_DEVIATION 0 • n=5 Participants
|
65.09 kg
STANDARD_DEVIATION 14.357 • n=4 Participants
|
|
BMI
|
23.875 kg/m2
STANDARD_DEVIATION 4.7718 • n=5 Participants
|
26.306 kg/m2
STANDARD_DEVIATION 5.1260 • n=7 Participants
|
27.192 kg/m2
STANDARD_DEVIATION 0 • n=5 Participants
|
24.962 kg/m2
STANDARD_DEVIATION 4.6311 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
7 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related TEAE
|
7 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Grade 3 or higher TEAE
|
6 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related Grade 3 or higher TEAE
|
5 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE leading to death
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAE
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
|
2 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 16 weeksThis 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
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
16-Week Progression-Free Survival (PFS) Rate
|
2 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
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
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=3 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Best Overall Response (BOR) by mRECIST v1.1
Best objective response of stable disease (SD)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response (BOR) by mRECIST v1.1
Best objective response of unequivocal progression (UPD)
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=3 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Estimate PFS by Modified RECIST v1.1
|
94 Days
Interval 1.0 to 113.0
|
64 Days
Interval 1.0 to 174.0
|
1 Days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 1 Day 7Population: 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
The area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) for INXN-1001
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
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
|
5935 ng*h/mL
Standard Deviation 2660
|
13350 ng*h/mL
Standard Deviation 0
|
|
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
|
10334 ng*h/mL
Standard Deviation 654
|
8604 ng*h/mL
Standard Deviation 0
|
|
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
|
105 ng*h/mL
Standard Deviation 16
|
266 ng*h/mL
Standard Deviation 0
|
|
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
|
193 ng*h/mL
Standard Deviation 74
|
171 ng*h/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
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
|
0 SFC/million PMBCs
Standard Deviation 0
|
0 SFC/million PMBCs
Standard Deviation 0
|
|
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
|
30 SFC/million PMBCs
Standard Deviation 42.43
|
0 SFC/million PMBCs
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
Serum levels of IFN-γ were measured by immunoassay to assess the pharmacodynamic effect of the treatment
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels
Screening: IFN-gamma (pg/mL)
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
|
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
|
309.4 pg/mL
Standard Deviation 358.37
|
68.1 pg/mL
Standard Deviation 0
|
|
Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels
Post-treatment Safety Assessment: IFN-gamma (pg/mL)
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
NA pg/mL
Standard Deviation NA
Below limit of quantitation (8.0 pg/mL) for all subjects
|
SECONDARY outcome
Timeframe: 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.
Serum levels of IL-12 were measured by immunoassay to assess the pharmacodynamic effect of the treatment
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Screening:Interleukin-12(pg/mL)
|
0.513 pg/mL
Standard Deviation 0.409
|
0.485 pg/mL
Standard Deviation 0.341
|
1.25 pg/mL
Standard Deviation 0
|
|
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
|
45.485 pg/mL
Standard Deviation 15.264
|
47.7 pg/mL
Standard Deviation 0
|
|
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
|
1.38 pg/mL
Standard Deviation 1.67
|
2.1 pg/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7Population: 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.
Absolute counts of CD3+ CD4+ helper T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Change From Baseline in CD3+ CD4+ T-Cell Count
Screening: CD3+CD4+ (cell/mcL)
|
845 cell/mcL
Standard Deviation 294.156
|
204.33 cell/mcL
Standard Deviation 82.59
|
263 cell/mcL
Standard Deviation 0
|
|
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
|
218.00 cell/mcL
Standard Deviation 114.55
|
104 cell/mcL
Standard Deviation 0
|
|
Change From Baseline in CD3+ CD4+ T-Cell Count
Follow-up Tumor Assessment: CD3+CD4+ (cell/mcL)
|
367.33 cell/mcL
Standard Deviation 75.80
|
290 cell/mcL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7Population: 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.
Absolute counts of CD3+ CD8+ cytotoxic T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
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
|
252.5 cell/mcL
Standard Deviation 106.77
|
159 cell/mcL
Standard Deviation 0
|
|
Change From Baseline in CD3+ CD8+ T-Cell Count
Screening: CD3+CD8+ (cell/mcL)
|
1021 cell/mcL
Standard Deviation 702.86
|
168 cell/mcL
Standard Deviation 87.88
|
558 cell/mcL
Standard Deviation 0
|
|
Change From Baseline in CD3+ CD8+ T-Cell Count
Follow-up Tumor Assessment: CD3+CD8+ (cell/mcL)
|
527.67 cell/mcL
Standard Deviation 441.00
|
150 cell/mcL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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
The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
Cmax (ng/mL) at C1D1
|
1024 ng/mL
Standard Deviation 705
|
536 ng/mL
Standard Deviation 218
|
1130 ng/mL
Standard Deviation 0
|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
Cmax (ng/mL) at C1D7
|
1403 ng/mL
Standard Deviation 55
|
706 ng/mL
Standard Deviation 81
|
749 ng/mL
Standard Deviation 0
|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
Dose-normalized m2/mg Cmax (ng/mL) at C1D1
|
11.1 ng/mL
Standard Deviation 5.5
|
9.7 ng/mL
Standard Deviation 2.6
|
22.5 ng/mL
Standard Deviation 0
|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
Dose-normalized m2/mg Cmax (ng/mL) at C1D7
|
17.8 ng/mL
Standard Deviation 6.3
|
13 ng/mL
Standard Deviation 4
|
14.9 ng/mL
Standard Deviation 0
|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
C24h (ng/mL) at C1D1
|
73.9 ng/mL
Standard Deviation 54.0
|
39.7 ng/mL
Standard Deviation 15.5
|
72 ng/mL
Standard Deviation 0
|
|
Maximum Plasma Concentration (Cmax) of INXN-1001
C24 (ng/mL) at C1D7
|
251 ng/mL
Standard Deviation 48.4
|
101 ng/mL
Standard Deviation 28
|
99 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 1 Day 7Population: 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
The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 Participants
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of INXN-1001
Tmax (h) at C1D1
|
3.7 hours
Standard Deviation 1.4
|
4.8 hours
Standard Deviation 2.5
|
4 hours
Standard Deviation 0
|
|
Time to Maximum Plasma Concentration (Tmax) of INXN-1001
Tmax (h) at C1D7
|
3.3 hours
Standard Deviation 1.2
|
3.0 hours
Standard Deviation 2
|
1 hours
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ad-RTS-hIL-12 + Veledimex 140 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Disease progression
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
General disorders
Pyrexia
|
28.6%
2/7 • Number of events 2 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • 16 months
|
0.00%
0/4 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
Vascular disorders
Superior vena cava syndrome
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
Other adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex 140 mg
n=7 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 140 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 100 mg Daily
n=4 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 100 mg daily for 7 days every 21-day cycle
|
Ad-RTS-hIL-12 + Veledimex 80 mg Daily
n=1 participants at risk
Ad-RTS-hIL-12 by intratumoral injection + Veledimex 80mg daily for 7 days every 21-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
3/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 4 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • 16 months
|
50.0%
2/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 4 • 16 months
|
75.0%
3/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 6 • 16 months
|
75.0%
3/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Number of events 9 • 16 months
|
75.0%
3/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 8 • 16 months
|
75.0%
3/4 • Number of events 3 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
General disorders
Chills
|
71.4%
5/7 • Number of events 7 • 16 months
|
50.0%
2/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1 • 16 months
|
50.0%
2/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Local swelling
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Localised oedema
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
General disorders
Asthena
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Oedema
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Oedema mucosal
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 2 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Immune system disorders
Seasonal allergy
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Infections and infestations
Herpes zoster
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
42.9%
3/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
28.6%
2/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Number of events 1 • 16 months
|
50.0%
2/4 • Number of events 4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood urea decreased
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood chloride increased
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Breath sounds abnormal
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Investigations
Protein total decreased
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 2 • 16 months
|
50.0%
2/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • 16 months
|
50.0%
2/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
42.9%
3/7 • Number of events 3 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.6%
2/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • Number of events 2 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 3 • 16 months
|
0.00%
0/1 • 16 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
28.6%
2/7 • Number of events 4 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Mylagia
|
14.3%
1/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 2 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 16 months
|
50.0%
2/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Nervous system disorders
Hypersomnia
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Renal and urinary disorders
Dysuria
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Reproductive system and breast disorders
Breast swelling
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • Number of events 3 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 4 • 16 months
|
0.00%
0/4 • 16 months
|
100.0%
1/1 • Number of events 1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • 16 months
|
25.0%
1/4 • Number of events 2 • 16 months
|
0.00%
0/1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
1/7 • Number of events 1 • 16 months
|
0.00%
0/4 • 16 months
|
0.00%
0/1 • 16 months
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • 16 months
|
25.0%
1/4 • Number of events 1 • 16 months
|
0.00%
0/1 • 16 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60