Trial Outcomes & Findings for A Trial Evaluating TG4050 in Ovarian Carcinoma. (NCT NCT03839524)
NCT ID: NCT03839524
Last Updated: 2025-11-14
Results Overview
Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Results posted on
2025-11-14
Participant Flow
A total of 64 patients consented to participate in the study. Of these, 58 (90.6%) were non-included-21 at study entry and 37 at baseline-while 6 patients were assigned to treatment.
Participant milestones
| Measure |
TG4050 Arm
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TG4050 Arm
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TG4050 Arm
n=6 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=6 Participants
|
|
Age, Continuous
|
73.5 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=6 Participants
|
|
Region of Enrollment
France
|
1 participants
n=6 Participants
|
|
BMI
|
29.3 kg/m²
STANDARD_DEVIATION 4.79 • n=6 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG status 0
|
5 Participants
n=6 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG status 1
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.Population: Safety Analysis Set (SAF): all patients included and who received at least one dose of TG4050.
Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Outcome measures
| Measure |
TG4050 Arm
n=6 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Fatal AE related toTG4050
|
0 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
AE leading to treatment discontinuation
|
1 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Fatal AE
|
1 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
AE related to TG4050 and leading to treatment discontinuation
|
0 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Serious Adverse Event
|
1 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Serious Adverse Event related to TG4050
|
0 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Grade 3/4 AE
|
0 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Adverse Event
|
6 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Dose Limiting Toxicity
|
0 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
AE related to TG4050
|
6 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Injection site reaction
|
6 Participants
|
|
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
AE related to other study procedure
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation.Population: Safety Analysis Set (SAF): all patients who received at least one dose of TG4050
Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 (Carbohydrate Antigen 125) serum level per the GCIC criteria (the Gynecological Cancer Intergroup).
Outcome measures
| Measure |
TG4050 Arm
n=6 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
CA-125 Response According to GCIC
|
1 Participants
|
SECONDARY outcome
Timeframe: Starting on Day 43 and then every nine weeks thereafter, until disease progression (estimated 12 months).Population: Safety Analysis Set (SAF): all patients included and who received at least one dose of TG4050.
Best overall response according to RECIST 1.1 was assessed for all patients, defined as follows: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
TG4050 Arm
n=6 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Tumor Response According to RECIST 1.1
Stable disease
|
3 Participants
|
|
Tumor Response According to RECIST 1.1
Progressive disease
|
3 Participants
|
SECONDARY outcome
Timeframe: 43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months).Population: Safety Analysis Set (SAF): all patients who received at least one dose of TG4050
Time to measurable relapse/progression per RECIST 1.1 (months) is defined as the time from the date of the first treatment injection until relapse or documented progressive disease, whichever occurs first, as assessed using CT scan or MRI.
Outcome measures
| Measure |
TG4050 Arm
n=6 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Time to Measurable Relapse/Progression Per RECIST 1.1
|
2.5 months
Interval 1.4 to 11.6
|
SECONDARY outcome
Timeframe: From informed consent (ICF) signature up to baseline.Population: Population of participants at baseline: 37 screen failures and 6 treated.
Percentage of consented participants who could not be enrolled in the TG4050 treatment period due to manufacturing failure.
Outcome measures
| Measure |
TG4050 Arm
n=43 Participants
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Failure to Provide Rate
|
3 Participants
|
Adverse Events
TG4050 Arm
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TG4050 Arm
n=6 participants at risk
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
Other adverse events
| Measure |
TG4050 Arm
n=6 participants at risk
Participants received subcutaneous injections of TG4050 at a dose of 1 × 10⁸ PFU weekly for the first six weeks, and then every three weeks, for up to a maximum of 20 injections.
As only one participant was treated in Cohort A (no measurable disease at treatment initiation), the results are presented by combining both cohorts, for a total of six participants.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site erythema
|
83.3%
5/6 • Number of events 13 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site pain
|
50.0%
3/6 • Number of events 11 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site mass
|
33.3%
2/6 • Number of events 7 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 3 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 3 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site irritation
|
16.7%
1/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site nodule
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site pruritus
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Infections and infestations
Covid-19
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
2/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Number of events 2 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • Number of events 1 • Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Adverse events (AEs) were summarized and presented by system organ class and preferred term for all participants who received at least one dose of the study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place