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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Institut Curie
Paris, France
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
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.
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).
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
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.
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 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.
Time frame: 43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months).
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Hôpital Pitié-Salpêtrière
Paris, France
IUCT Toulouse
Toulouse, France
Failure to Provide Rate
Percentage of consented participants who could not be enrolled in the TG4050 treatment period due to manufacturing failure.
Time frame: From informed consent (ICF) signature up to baseline.