The primary objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Short-term intravenous (IV) infusion.
City of Hope National Medical Center
Duarte, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Inselspital Bern
Bern, Switzerland
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 28
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, electrocardiograms, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
Time frame: Day 1 to a maximum of 2 years
Number of Participants Who Experience a Treatment-related AE
Time frame: Day 1 to a maximum of 2 years
Minimum Efficacious Dose (MED)
Defined as the first unconfirmed partial response (PR) or better.
Time frame: Day 1 to a maximum of 2 years
Maximum Observed Serum Concentration (Cmax) of AMG 794
Time frame: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Minimum Observed Serum Concentration (Cmin) of AMG 794
Time frame: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 794
Time frame: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Confirmed objective response (OR)
Defined as best overall response \[BOR\] of complete response \[CR\] or PR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Day 1 to a maximum of 2 years
Confirmed OR
Defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR) based on Immune RECIST (iRECIST).
Time frame: Day 1 to a maximum of 2 years
Cancer Antigen (CA) 125 Response
CA 125 response will be analyzed in the Ovarian Cancer Analysis Set, defined as all participants with a primary tumor type of ovarian cancer who are enrolled and receive at least 1 dose of AMG 794.
Time frame: Day 1 to a maximum of 2 years
Duration of Response
Defined as the time from the first documentation of OR until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Day 1 to a maximum of 2 years
Time to Progression
Defined as the time from enrollment until the first documentation of radiological disease progression.
Time frame: Day 1 to a maximum of 2 years
Progression-free Survival (PFS)
Defined as the time from enrollment until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first.
Time frame: Day 1 to a maximum of 2 years
1-year Overall Survival (OS)
Time frame: 1 year
2-year OS
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.