A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2 will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase who have demonstrated Clinical Benefit by Week 16.
Subjects will receive doses of FF-10502-01 intravenously (IV) weekly for three weeks, repeated every 28 days (= 1 cycle). Disease assessments, based on computed tomography (CT), magnetic resonance image (MRI), and, for lymphoma, \[18F\]-fluorodeoxyglucose positron emission tomography (FDG-PET) scans, will be obtained at Week 8 and every 8 weeks thereafter until documented progression of disease (PD). Subjects who demonstrate clinical benefit will be allowed to continue therapy with FF-10502-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Time frame: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Number of Subjects With Overall Response Rates (ORR)
Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable
Time frame: Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
Number of Subjects With Objective Response (OR) Events
Number of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Objective Response (OR)
Median duration of objective response in days for each cohort".
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Stable Disease (SD) Events
Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
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Median Number of Days of Stable Disease (SD)
Median duration of stable disease (SD) in days for each cohort
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Progression-free Survival (PFS) Events
Number of subjects with progressive disease or death and number of subject censored.
Time frame: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Progression-free Survival (PFS)
This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort
Time frame: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Overall Survival (OS) Events
Number of subjects with overall survival (OS) events in each cohort
Time frame: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Overall Survival (OS)
Median number of days of overall survival (OS) for each cohort
Time frame: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months