Ovarian CarcinomaPhase 1NCT03839524
A Trial Evaluating TG4050 in Ovarian Carcinoma.
A Phase 1 study testing TG4050 in people with Ovarian Carcinoma and Fallopian Tube Cancer, run by Transgene at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Fallopian Tube Cancer, Peritoneal Carcinoma
- What is being tested?
- TG4050
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Dec 2019to 8 Oct 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Female patients ≥ 18 years
- Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
- Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked.
- Patients must have achieved a complete response to therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation
- Adequate hematological, hepatic and renal functions.
Who cannot join
- Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4)
- Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
- Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
- Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
- Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
- Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
Show all 11Show fewer
- Major surgery within 4 weeks of treatment start.
- Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
- Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
- Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
- Uncontrolled intercurrent illness.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Phoenix
Phoenix, Arizona, 85259
Mayo Clinic Rochester
Rochester, Minnesota, 55905
France3 sites
Institut Curie
Paris, 75005
Hôpital Pitié-Salpêtrière
Paris, 75013
IUCT Toulouse
Toulouse, 31100
About this study
Official title: A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.
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.
- Being tested
- TG4050
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG4050Drug
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TG4050 arm | Experimental | Patients in this arm will receive injections of TG4050 Investigational Medicinal Product. Receives: Drug: TG4050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (4)
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).
Measured: Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation.
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.
Measured: 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.
Measured: 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.
Measured: From informed consent (ICF) signature up to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start9 Dec 2019
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839524
- Sponsor's protocol ID
- TG4050.01
- Status last verified
- Oct 2025
- First submitted
- 6 Feb 2019
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.
- ClinicalTrials.gov ID
- NCT03839524
- Acronym / sponsor ID
- TG4050.01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- TransgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG4050 arm | Experimental | Drug: TG4050Patients in this arm will receive injections of TG4050 Investigational Medicinal Product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent.
- Female patients ≥ 18 years
- Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
- Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked.
- Patients must have achieved a complete response to therapy
Key exclusion criteria (11 listed)
- Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4)
- Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
- Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
- Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
- Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG4050Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks. | Drug | TG4050 arm |
Primary outcome
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
Time frame: 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.
Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
4 secondary outcomes
CA-125 Response According to GCIC
Time frame: Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation.
Tumor Response According to RECIST 1.1
Time frame: 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 frame: 43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months).
Failure to Provide Rate
Time frame: From informed consent (ICF) signature up to baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ovarian Carcinoma
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG4050 in people with Ovarian Carcinoma and Fallopian Tube Cancer, run by Transgene at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (Adverse Event Reported Per CTCAE v5) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.