The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
464
AMG 436 will be administered.
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
RECRUITINGNumber of Participants with a Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Maximum Serum Concentration (Cmax) of AMG 436
Time frame: Up to 57 days
Minimum Serum Concentration (Cmin) of AMG 436
Time frame: Up to 57 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436
Time frame: Up to 57 days
Time to Achieve Cmax (Tmax) of AMG 436
Time frame: Up to 57 days
Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State
Time frame: Up to 24 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 5 years
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Midwestern Regional Medical Center dba City of Hope Chicago
Zion, Illinois, United States
New England Cancer Specialists
Westbrook, Maine, United States
RECRUITINGTennessee Oncology PLLC
Nashville, Tennessee, United States
RECRUITINGNext Oncology - Dallas
Irving, Texas, United States
RECRUITINGCalvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGUniversite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGZhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING...and 6 more locations
Time to Response (TTR) per RECIST v1.1
Time frame: Up to 5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 5 years
Overall Survival (OS) per RECIST v1.1
Time frame: Up to 5 years
Change From Baseline in Tumor Phosphorylated Checkpoint Kinase 2 (CHK2) Following AMG 436
Time frame: Baseline up to 5 years