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Trial Outcomes & Findings for A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer (NCT NCT02423902)

NCT ID: NCT02423902

Last Updated: 2025-08-28

Results Overview

Composite measure of safety and tolerability based on lab parameters, vitals, physical examination data and deaths, SAEs, and AEs resulting in patient discontinuation. Toxicity stopping rules when applicable will be determined based on a clinical assessment made by the SRC. The Sponsor conducted an additional ad hoc analysis of study-drug-related-TEAEs with an onset during the dosing period of all cycles to assess the number subjects with events of cytokine release syndrome (CRS), to include TEAEs that were symptoms of CRS, including when the PI did not report the preferred term of CRS. Results of this ad hoc assessment are reported here.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2025-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
HER2+ Subjects
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Overall Study
STARTED
1
8
Overall Study
COMPLETED
0
4
Overall Study
NOT COMPLETED
1
4

Reasons for withdrawal

Reasons for withdrawal
Measure
HER2+ Subjects
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Overall Study
Disease progression
1
4

Baseline Characteristics

A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Total
n=9 Participants
Total of all reporting groups
Age, Continuous
39.0 years
STANDARD_DEVIATION 0 • n=99 Participants
50.9 years
STANDARD_DEVIATION 10.24 • n=107 Participants
49.6 years
STANDARD_DEVIATION 10.38 • n=206 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
8 Participants
n=107 Participants
9 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=99 Participants
7 Participants
n=107 Participants
8 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
6 Participants
n=107 Participants
6 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Height
167.0 cm
STANDARD_DEVIATION 0 • n=99 Participants
161.1 cm
STANDARD_DEVIATION 4.72 • n=107 Participants
161.8 cm
STANDARD_DEVIATION 4.83 • n=206 Participants
Weight
71.0 kg
STANDARD_DEVIATION 0 • n=99 Participants
63.2 kg
STANDARD_DEVIATION 11.75 • n=107 Participants
64.1 kg
STANDARD_DEVIATION 11.29 • n=206 Participants
BMI
25.5 kg/m2
STANDARD_DEVIATION 0 • n=99 Participants
24.5 kg/m2
STANDARD_DEVIATION 5.02 • n=107 Participants
24.6 kg/m2
STANDARD_DEVIATION 4.71 • n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The safety population will comprise all subjects who have received either the injection of Ad-RTS-hIL-12 or any doses of veledimex

Composite measure of safety and tolerability based on lab parameters, vitals, physical examination data and deaths, SAEs, and AEs resulting in patient discontinuation. Toxicity stopping rules when applicable will be determined based on a clinical assessment made by the SRC. The Sponsor conducted an additional ad hoc analysis of study-drug-related-TEAEs with an onset during the dosing period of all cycles to assess the number subjects with events of cytokine release syndrome (CRS), to include TEAEs that were symptoms of CRS, including when the PI did not report the preferred term of CRS. Results of this ad hoc assessment are reported here.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Any TEAE
1 participants
8 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Treatment-related TEAE
1 participants
8 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Grade 3 or higher TEAE
1 participants
7 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Treatment-related Grade 3 or higher TEAE
1 participants
6 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Adverse event leading to death
0 participants
0 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Serious TEAE
0 participants
4 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
TEAE leading to discontinuation
0 participants
5 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Cytokine Release Syndrome Assessment: Grade 2
1 participants
5 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Cytokine Release Syndrome Assessment: Grade 3
0 participants
2 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Study Discontinuation
Cytokine Release Syndrome Assessment: Grade 4
0 participants
1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The veledimex-treated population will comprise subjects who have received the injection of Ad-RTS-hIL-12 and at least one dose of veledimex

The percent of subjects that failed by 12 weeks is denoted as the progression rate, and is derived based on the sum of progression events, death events, and subjects who discontinue the trial due to an AE. Tumor assessment was performed per RECIST (progression was determined as \>=20% increase in the sum of the longest diameter of target lesions and or unequivocal new lesion were present)

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Progression Rate at 12 Weeks After the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
12-week Progression rate per RECIST criteria
100.0 % of subjects who progressed at 12 weeks
Interval 2.5 to 100.0
62.5 % of subjects who progressed at 12 weeks
Interval 24.5 to 91.5
Progression Rate at 12 Weeks After the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
12-week Progression rate per irRC criteria
100.0 % of subjects who progressed at 12 weeks
Interval 2.5 to 100.0
75.0 % of subjects who progressed at 12 weeks
Interval 34.9 to 96.8

SECONDARY outcome

Timeframe: 12 weeks

Population: The veledimex-treated population will comprise subjects who have received the injection of Ad-RTS-hIL-12 and at least one dose of veledimex

Overall response at Week 12 is based on the totality of the responses for target and non-target lesions. For this calculation, responders are defined as those experiencing a CR or a PR. Non-responders are those either with stable or progressive disease. Those subjects who cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Overall Response Rate (ORR), Defined as the Rate of Complete Response (CR) Plus the Rate of Partial Response (PR) at 12 Weeks Following the Start of Ad-RTS-hIL-12 Immunotherapy
Objective response rate (CR or PR) at Week 12 per RECIST
0.0 Percentage of subjects with CR or PR
Interval 0.0 to 97.5
12.5 Percentage of subjects with CR or PR
Interval 0.3 to 52.7
Overall Response Rate (ORR), Defined as the Rate of Complete Response (CR) Plus the Rate of Partial Response (PR) at 12 Weeks Following the Start of Ad-RTS-hIL-12 Immunotherapy
Objective response rate (CR or PR) at Week 12 per irRC
0.0 Percentage of subjects with CR or PR
Interval 0.0 to 97.5
12.5 Percentage of subjects with CR or PR
Interval 0.3 to 52.7

SECONDARY outcome

Timeframe: 12 weeks

Population: The veledimex-treated population will comprise subjects who have received the injection of Ad-RTS-hIL-12 and at least one dose of veledimex

The DCR is the proportion of subjects who have a CR, PR, or stable disease at 12 weeks following the start of Ad-RTS-hIL-12 immunotherapy using RECIST v1.1. For this calculation, responders are defined as those experiencing a CR, PR, or stable disease. Non-responders are defined as those with PD. Those subjects that cannot be assessed will be treated as non-responders for the purposes of deriving the percentage of responders and confidence intervals.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Disease Control Rate (DCR), Defined as the Proportion of Subjects Who Have a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at 12 Weeks Following the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
Disease control rate (CR, PR, or SD) at Week 12 per RECIST
0.0 Percentage of subjects with CR, PR, or S
Interval 0.0 to 97.5
25.0 Percentage of subjects with CR, PR, or S
Interval 3.2 to 65.1
Disease Control Rate (DCR), Defined as the Proportion of Subjects Who Have a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at 12 Weeks Following the Start of One Cycle of Ad-RTS-hIL-12 Immunotherapy
Disease control rate (CR, PR, or SD) at Week 12 per irRC
0.0 Percentage of subjects with CR, PR, or S
Interval 0.0 to 97.5
25.0 Percentage of subjects with CR, PR, or S
Interval 3.2 to 65.1

SECONDARY outcome

Timeframe: 12 weeks

Population: The veledimex-treated population will comprise subjects who have received the injection of Ad-RTS-hIL-12 and at least one dose of veledimex

Number of subjects whose baseline tumor status (stable disease or partial response) improves to partial response or better at 12 weeks following the start of Ad-RTS-hIL-12 immunotherapy

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Number of Subjects Whose Baseline Tumor Status (Stable Disease or Partial Response) Improves to Partial Response or Better at 12 Weeks Following the Start of Ad-RTS-hIL-12 Immunotherapy
0 participants
1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The veledimex-treated population will comprise subjects who have received the injection of Ad-RTS-hIL-12 and at least one dose of veledimex

Best Overall Response at Week 12 after 1 cycle of Ad-RTS-hIL-12 + veledimex immunotherapy is reported for response assessment per RECIST and per irRC.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Comparison of Radiographic Tumor Responses by irRC With RECIST
Partial response per RECIST
0 participants
1 participants
Comparison of Radiographic Tumor Responses by irRC With RECIST
Partial response per irRC
0 participants
1 participants
Comparison of Radiographic Tumor Responses by irRC With RECIST
Stable disease per RECIST
0 participants
3 participants
Comparison of Radiographic Tumor Responses by irRC With RECIST
Stable disease per irRC
0 participants
2 participants
Comparison of Radiographic Tumor Responses by irRC With RECIST
Progressive disease per RECIST
1 participants
4 participants
Comparison of Radiographic Tumor Responses by irRC With RECIST
irRProgressive disease per irRC
1 participants
5 participants

SECONDARY outcome

Timeframe: Screening, Week 6, and Week 12

Population: The analysis was performed on the Veledimex-treated population. The number of subjects analyzed at each time point may be lower than the total due to missed sample collections.

Serum levels of the cancer antigen 15-3 (CA15-3) biomarker were measured by immunoassay to explore the impact of treatment.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Change From Baseline in Serum CA15-3 Levels
CA15-3 (Muc-1) at Screening
91 U/ml
Standard Deviation 0
1281.5 U/ml
Standard Deviation 3500.774
Change From Baseline in Serum CA15-3 Levels
CA15-3 (Muc-1) at Week 6
138 U/ml
Standard Deviation 0
3747.5 U/ml
Standard Deviation 10430.77
Change From Baseline in Serum CA15-3 Levels
CA15-3 (Muc-1) at Week 12
—
76.75 U/ml
Standard Deviation 101.6772

SECONDARY outcome

Timeframe: Screening, Week 6, and Week 12

Population: The analysis was performed on the Veledimex-treated population. The number of subjects analyzed at each time point may be lower than the total due to missed sample collections.

Serum levels of Interleukin-12 (IL-12) were measured by immunoassay to explore the impact of treatment on immune biomarkers.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Il-12 at Screening
0.1505 pg/mL
0.0728 pg/mL
Standard Deviation 0.0901
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Il-12 at Week 6
0.735 pg/mL
0.1476 pg/mL
Standard Deviation 0.1436
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Il-12 at Week 12
—
0.0244 pg/mL
Standard Deviation 0.0221

SECONDARY outcome

Timeframe: Screening, Week 6, and Week 12

Population: The analysis was performed on the Veledimex-treated population. The number of subjects analyzed at each time point may be lower than the total due to missed sample collections

Serum levels of Interferon-gamma (IFN-gamma) were measured by immunoassay to explore the impact of treatment on immune biomarkers.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Change From Baseline in Serum Interferon-gamma (IFN-gamma) Levels
IFN-gamma at Screening
6.34 pg/mL
7.34 pg/mL
Standard Deviation 10.32
Change From Baseline in Serum Interferon-gamma (IFN-gamma) Levels
IFN-gamma at Week 6
6.87 pg/mL
6.51 pg/mL
Standard Deviation 6.06
Change From Baseline in Serum Interferon-gamma (IFN-gamma) Levels
IFN-gamma at Week 12
—
7.02 pg/mL
Standard Deviation 6.24

SECONDARY outcome

Timeframe: Screening, Week 6, and Week 12.

Population: The analysis was performed on the Veledimex-treated population. The number of subjects analyzed at each time point may be lower than the total due to missed sample collections.

Serum levels of the carcinoembryonic antigen (CEA) biomarker were measured by immunoassay to explore the impact of treatment.

Outcome measures

Outcome measures
Measure
HER2+ Subjects
n=1 Participants
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 Participants
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Change From Baseline in Serum Carcinoembryonic Antigen (CEA) Levels
CEA at Screening
5.1 ng/mL
8.275 ng/mL
Standard Deviation 9.970
Change From Baseline in Serum Carcinoembryonic Antigen (CEA) Levels
CEA at Week 6
7.5 ng/mL
14.838 ng/mL
Standard Deviation 21.690
Change From Baseline in Serum Carcinoembryonic Antigen (CEA) Levels
CEA at Week 12
—
4.225 ng/mL
Standard Deviation 3.226

Adverse Events

HER2+ Subjects

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

HER2- Subjects

Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
HER2+ Subjects
n=1 participants at risk
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 participants at risk
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Blood and lymphatic system disorders
Febrile Neutropenia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
General disorders
Fatigue
0.00%
0/1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
General disorders
Malaise
0.00%
0/1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Infections and infestations
Lung Infection
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Investigations
Alanine Aminotransferase Increased
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Investigations
Aspartate Aminotransferase Increased
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Vascular disorders
Hypotension
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure
HER2+ Subjects
n=1 participants at risk
Subjects with HER2+ breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
HER2- Subjects
n=8 participants at risk
Subjects with HER2- breast cancer were assigned to receive an intratumoral injection of Ad-RTS-hIL-12 in combination with veledimex: * Ad-RTS-hIL-12: Approximately 1.0x10\^12 viral particles (vp) per injection * Veledimex: 7 oral doses of veledimex
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Cardiac disorders
Palpitations
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Cardiac disorders
Tachycardia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Eye disorders
Dry Eye
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Gastrointestinal disorders
Vomiting
100.0%
1/1 • Number of events 1 • 1 year
50.0%
4/8 • Number of events 5 • 1 year
Gastrointestinal disorders
Nausea
100.0%
1/1 • Number of events 1 • 1 year
37.5%
3/8 • Number of events 3 • 1 year
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
100.0%
1/1 • Number of events 1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Gastrointestinal disorders
Constipation
0.00%
0/1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Gastrointestinal disorders
Flatulence
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Gastrointestinal disorders
Diarrhoea
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Gastrointestinal disorders
Dyspepsia
100.0%
1/1 • Number of events 1 • 1 year
0.00%
0/8 • 1 year
Gastrointestinal disorders
Gingival Pain
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
General disorders
Pyrexia
100.0%
1/1 • Number of events 2 • 1 year
75.0%
6/8 • Number of events 9 • 1 year
General disorders
Fatigue
100.0%
1/1 • Number of events 1 • 1 year
62.5%
5/8 • Number of events 8 • 1 year
General disorders
Chills
100.0%
1/1 • Number of events 1 • 1 year
62.5%
5/8 • Number of events 6 • 1 year
General disorders
Malaise
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
General disorders
Asthenia
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
General disorders
Localised Oedema
100.0%
1/1 • Number of events 1 • 1 year
0.00%
0/8 • 1 year
Infections and infestations
Urinary Tract Infection
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Investigations
Aspartate Aminotransferase Increased
100.0%
1/1 • Number of events 2 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Investigations
Alanine Aminotransferase
100.0%
1/1 • Number of events 1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Investigations
Lymphocyte Count Decreased
0.00%
0/1 • 1 year
50.0%
4/8 • Number of events 4 • 1 year
Investigations
Blood Alkaline Phosphatase Increased
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Investigations
Neutrophil Count Decreased
0.00%
0/1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Investigations
Blood Bilirubin Increased
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Investigations
White Blood Cell Count Decreased
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Metabolism and nutrition disorders
Decreased Appetite
100.0%
1/1 • Number of events 1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders
Myalgia
100.0%
1/1 • Number of events 1 • 1 year
62.5%
5/8 • Number of events 5 • 1 year
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Nervous system disorders
Headache
100.0%
1/1 • Number of events 1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/1 • 1 year
25.0%
2/8 • Number of events 2 • 1 year
Nervous system disorders
Dysgeusia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Nervous system disorders
Paraesthesia
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Psychiatric disorders
Depression
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Reproductive system and breast disorders
Breast Pain
100.0%
1/1 • Number of events 1 • 1 year
0.00%
0/8 • 1 year
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
100.0%
1/1 • Number of events 1 • 1 year
0.00%
0/8 • 1 year
Respiratory, thoracic and mediastinal disorders
Cough
100.0%
1/1 • Number of events 1 • 1 year
0.00%
0/8 • 1 year
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year
Vascular disorders
Hypotension
0.00%
0/1 • 1 year
37.5%
3/8 • Number of events 3 • 1 year
Vascular disorders
Hypertension
0.00%
0/1 • 1 year
12.5%
1/8 • Number of events 1 • 1 year

Additional Information

Jaymes Holland

Alaunos Therapeutics

Phone: 6502732627

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60