A Trial Evaluating TG4050 in Ovarian Carcinoma.

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.

Study Overview

• Status: Completed
• Conditions: Fallopian Tube Cancer; Peritoneal Carcinoma; Ovarian Carcinoma
• Intervention / Treatment: Drug: TG4050

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière
  • Toulouse, France, 31100
    • IUCT Toulouse
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • Mayo Clinic Phoenix
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent.
2. Female patients ≥ 18 years
3. Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
4. 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.
5. Patients must have achieved a complete response to therapy
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation
7. Adequate hematological, hepatic and renal functions.

Exclusion Criteria:

1. 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)
2. Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
3. Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
4. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
5. Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
6. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
7. Major surgery within 4 weeks of treatment start.
8. Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
9. Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
10. 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.
11. Uncontrolled intercurrent illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TG4050 arm; Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.	Drug: TG4050; Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Transgene

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms
• Other Study ID Numbers: TG4050.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No