Clinical Trials /

A Trial Evaluating TG4050 in Ovarian Carcinoma.

NCT03839524

Description:

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.

Related Conditions:
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial Evaluating TG4050 in Ovarian Carcinoma.
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: TG4050.01
  • NCT ID: NCT03839524

Conditions

  • Ovarian Carcinoma
  • Fallopian Tube Cancer
  • Peritoneal Carcinoma

Interventions

DrugSynonymsArms
TG4050TG4050 arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TG4050 armExperimentalPatients in this arm will receive injections of TG4050 Investigational Medicinal Product.
  • TG4050

Eligibility Criteria

        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 and have completed standard
             first-line platinum-based chemotherapy for whom tumor tissue has been banked from
             previous abdominal surgery.

          5. Patients must have achieved a complete response to therapy

          6. Adequate hematological, hepatic and renal functions

        Exclusion Criteria:

          1. Patient having received:

               -  Neoadjuvant chemotherapy prior to debulking surgery

               -  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, and 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 non-oncology vaccine therapy for prevention of infectious diseases during the
             four-week period prior to TG4050 treatment initiation planned date.

         11. Uncontrolled intercurrent illness
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability (Adverse Event reported per CTCAE v5)
Time Frame:At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks
Safety Issue:
Description:Incidence of Adverse Event reported per CTCAE v5

Secondary Outcome Measures

Measure:Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria
Time Frame:Every 3 weeks
Safety Issue:
Description:Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria.
Measure:Best Overall Tumor Response Rate
Time Frame:Within 21 days of treatment initiation and then every 9 weeks
Safety Issue:
Description:Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the the total number of patients evaluable.
Measure:Rate of patients with immune response
Time Frame:Days 64, 85 and 211
Safety Issue:
Description:Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Transgene

Last Updated

December 7, 2019