The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Intravenous (IV) infusion.
Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 28
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
Time frame: 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
Time frame: Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Objective Response (OR) Rate
OR = complete response (CR) + partial response (PR), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time frame: Up to approximately 2 years
Part 1: OR Rate
OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.
Time frame: Up to approximately 2 years
Parts 1 and 2: Disease Control (DC) Rate
DC = CR, PR, or stable disease (SD).
Time frame: Up to approximately 2 years
Parts 1 and 2: Duration of Response (DOR)
DOR, defined as the time from first documentation of OR (as determined by investigator per RECIST v1.1) until the first documentation of disease progression or death due to any cause, whichever occurs first. Only participants who have achieved OR will be evaluated for DOR. DOR will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
City of Hope National Medical Center
Duarte, California, United States
University of California Irvine
Orange, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
US Oncology Research Investigational Products Center
Irving, Texas, United States
Texas Oncology Northeast Texas
Tyler, Texas, United States
...and 105 more locations
Time frame: Up to approximately 2 years
Parts 1 and 2: Time to Response
Time frame: Up to approximately 2 years
Parts 1 and 2: Progression-free Survival (PFS)
PFS, defined as time from first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause. PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent therapy. Progression will be based on RECIST v1.1 (derived utilizing investigator tumor assessments).
Time frame: Up to approximately 2 years
Parts 1 and 2: Overall Survival (OS)
OS, defined as time from first dose of investigational product until death from any cause. Participants still alive will be censored at the date last known to be alive.
Time frame: Up to approximately 2 years
Part 2: Number of Participants Who Experience a TEAE
AEs are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
Time frame: Day 1 to 28 days after last dose (a maximum of 2 years)
Part 2: Number of Participants Who Experience a Treatment-related AE
Time frame: 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
Time frame: Day 1 to 28 days after last dose (a maximum of 2 years)
Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Time frame: 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
Time frame: Day 1 to 28 days after last dose (a maximum of 2 years)