A Trial Evaluating TG4050 in Ovarian Carcinoma.

NCT03839524 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: TG4050.01
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Ovarian Carcinoma; Fallopian Tube Cancer; Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• CA-125 Response According to GCIC

  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

  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

  43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months).

• Failure to Provide Rate

  From informed consent (ICF) signature up to baseline.

Study Arms (1)

TG4050 arm

EXPERIMENTAL

Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.

Drug: TG4050

Interventions

TG4050 DRUG

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.

TG4050 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Transgene: lead

Study Sites (6)

Mayo Clinic Phoenix

Phoenix, Arizona, 85259, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

IUCT Toulouse

Toulouse, 31100, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: TRANSGENE

clinical.trials@transgene.fr

+ 33 3 88 27 91 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: December 9, 2019
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Locations

US (3); FR (3)