Recruiting
Sponsor ID
20250004
AMG 436 as Monotherapy and Combination Therapy in Participants with MSI-H/dMMR Solid Tumors
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants with a Dose Limiting Toxicity (DLT)
Timeframe: Up to 21 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 5 years
Secondary Outcome Measures
Maximum Serum Concentration (Cmax) of AMG 436
Timeframe: Up to 57 days
Minimum Serum Concentration (Cmin) of AMG 436
Timeframe: Up to 57 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436
Timeframe: Up to 57 days
Time to Achieve Cmax (Tmax) of AMG 436
Timeframe: Up to 57 days
Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State
Timeframe: Up to 24 days
Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to 5 years
Duration of Response (DOR) per RECIST v1.1
Timeframe: Up to 5 years
Time to Response (TTR) per RECIST v1.1
Timeframe: Up to 5 years
Disease Control Rate (DCR) per RECIST v1.1
Timeframe: Up to 5 years
Progression-free Survival (PFS) per RECIST v1.1
Timeframe: Up to 5 years
Overall Survival (OS) per RECIST v1.1
Timeframe: Up to 5 years
Change From Baseline in Tumor Phosphorylated Checkpoint Kinase 2 (CHK2) Following AMG 436
Timeframe: Baseline up to 5 years
Locations
Location
Next Oncology - Dallas
Irving, TX, United States, 75039
Status
Recruiting
Location
Aichi Cancer Center
Nagoya-shi, Aichi, Japan, 464-8681
Status
Recruiting
Location
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Status
Recruiting
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Recruiting
Location
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
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