This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients. Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Time frame: 4 weeks on average
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
Time frame: 16 weeks on average
Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
Time frame: 16 weeks on average
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 16 weeks on average
Duration of Response Per RECIST 1.1 (Part 2 Only)
Duration of complete or partial response with 95% confidence intervals in gastric cancer population.
Time frame: 16 weeks on average
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve
Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2. • Summary of area under serum concentration-time curve, maximum serum concentration,
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco, California, United States
Innovative Cancer Research Institute
Whittier, California, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States
...and 16 more locations
Time frame: 16 weeks on average