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.
Number 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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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