A Study Evaluating Bemarituzumab in Solid Tumors with fibroblast growth factor receptor 2b (FGFR2b) OverexpressionFORTITUDE-301
Study Details
The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
Protocol Summary
Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Timeframe: Day 1 to Day 28
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Part 1: Number of Participants Who Experience a Treatment-related Adverse Event
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Objective Response (OR) Rate
Timeframe: Up to approximately 2 years
Part 1: OR Rate
Timeframe: Up to approximately 2 years
Parts 1 and 2: Disease Control (DC) Rate
Timeframe: Up to approximately 2 years
Parts 1 and 2: Duration of Response (DOR)
Timeframe: Up to approximately 2 years
Parts 1 and 2: Time to Response
Timeframe: Up to approximately 2 years
Parts 1 and 2: Progression-free Survival (PFS)
Timeframe: Up to approximately 2 years
Parts 1 and 2: Overall Survival (OS)
Timeframe: Up to approximately 2 years
Part 2: Number of Participants Who Experience a TEAE
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Number of Participants Who Experience a Treatment-related AE
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)