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This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG4050 arm | Experimental | Patients in this arm will receive injections of TG4050 Investigational Medicinal Product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG4050 | Drug | Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (Adverse Event Reported Per CTCAE v5) | Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CA-125 Response According to GCIC | 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). | Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Phoenix | Arizona | 85259 | United States | ||
| Mayo Clinic Jacksonville |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability (Adverse Event Reported Per CTCAE v5) | Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | Safety Analysis Set (SAF): all patients included and who received at least one dose of TG4050. | Posted | Count of Participants | Participants | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment | The serious adverse event is not related to the treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
Due to challenges in patient accrual, the expected sample size was not reached, rendering the originally planned secondary objectives irrelevant given the limited number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | TRANSGENE | + 33 3 88 27 91 00 | clinical.trials@transgene.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2023 | Oct 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2025 | Oct 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Tumor Response According to RECIST 1.1 | 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. | Starting on Day 43 and then every nine weeks thereafter, until disease progression (estimated 12 months). |
| Time to Measurable Relapse/Progression Per RECIST 1.1 | 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. | 43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months). |
| Failure to Provide Rate | Percentage of consented participants who could not be enrolled in the TG4050 treatment period due to manufacturing failure. | From informed consent (ICF) signature up to baseline. |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Institut Curie | Paris | 75005 | France |
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| IUCT Toulouse | Toulouse | 31100 | France |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m² |
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| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | The Eastern Cooperative Oncology Group (ECOG) score is an overall assessment of the functional/physical performance of the patient. 0=Fully active, able to carry on all pre-disease performance without restriction. 1=Restricted in strenuous activity but ambulatory and able to carry out work of a sedentary nature. | Count of Participants | Participants |
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| Secondary | CA-125 Response According to GCIC | 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). | Safety Analysis Set (SAF): all patients who received at least one dose of TG4050 | Posted | Count of Participants | Participants | Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation. |
|
|
|
| Secondary | Tumor Response According to RECIST 1.1 | 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. | Safety Analysis Set (SAF): all patients included and who received at least one dose of TG4050. | Posted | Count of Participants | Participants | Starting on Day 43 and then every nine weeks thereafter, until disease progression (estimated 12 months). |
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|
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| Secondary | Time to Measurable Relapse/Progression Per RECIST 1.1 | 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. | Safety Analysis Set (SAF): all patients who received at least one dose of TG4050 | Posted | Median | Inter-Quartile Range | months | 43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months). |
|
|
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| Secondary | Failure to Provide Rate | Percentage of consented participants who could not be enrolled in the TG4050 treatment period due to manufacturing failure. | Population of participants at baseline: 37 screen failures and 6 treated. | Posted | Count of Participants | Participants | From informed consent (ICF) signature up to baseline. |
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| 1 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site irritation | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |