Phase 1
N=6
A Trial Evaluating TG4050 in Ovarian Carcinoma.
Ovarian Carcinoma · Fallopian Tube Cancer · Peritoneal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03839524 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Nov 2025
Primary outcome: Primary: Safety and Tolerability (Adverse Event Reported Per CTCAE v5) — 6; 0; 6; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TG4050 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Transgene
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability (Adverse Event Reported Per CTCAE v5) |
6; 0; 6; 6; 0; 1 | — |
| SECONDARY CA-125 Response According to GCIC |
1 | — |
| SECONDARY Tumor Response According to RECIST 1.1 |
3; 3 | — |
| SECONDARY Time to Measurable Relapse/Progression Per RECIST 1.1 |
2.5 | — |
| SECONDARY Failure to Provide Rate |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT03839524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.