City of Hope National Medical Center 91010 Duarte United StatesRekrutierend» Google-MapsHackensack University Medical Center 07601 Hackensack United StatesRekrutierend» Google-MapsNew York University Cancer Institute 10016 New York United StatesRekrutierend» Google-MapsThomas Jefferson University 19107 Philadelphia United StatesRekrutierend» Google-MapsSarah Cannon Research Institute 37203 Nashville United StatesRekrutierend» Google-MapsNext Oncology 78229 San Antonio United StatesRekrutierend» Google-MapsChris OBrien Lifehouse 2050 Camperdown AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Centre 3000 Melbourne AustraliaRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse Oncopole 31059 Toulouse cedex 9 FranceRekrutierend» Google-MapsGustave Roussy 94805 Villejuif FranceRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa-shi JapanRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsHospital Clinic i Provincial de Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital Universitario Madrid Sanchinarro 28050 Madrid SpainRekrutierend» Google-Maps
1. Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) (Time Frame - Day 1 to Day 28)
2. Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) (Time Frame - Up to a maximum of 2 years): 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 (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
3. Percentage of Participants who Experience Treatment-Related Adverse Events (Time Frame - Up to a maximum of 2 years)
Secondary outcome:
1. Maximum Serum Concentration (Cmax) of AMG 305 (Time Frame - Up to a maximum of 2 years)
2. Minimum Serum Concentration (Cmin) of AMG 305 (Time Frame - Up to a maximum of 2 years)
3. Area Under the Concentration-Time Curve (AUC) of AMG 305 (Time Frame - Up to a maximum of 2 years)
4. Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Time Frame - Up to a maximum of 2 years): ORR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), Clinical Benefit Rate (defined as BOR of CR, PR, or stable disease [SD] with duration of 24 weeks or longer) based on RECIST v1.1.
5. ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (Time Frame - Up to a maximum of 2 years): ORR is defined as immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR), Clinical Benefit Rate (defined as iBOR of iCR, iPR, or immune stable disease [iSD] with duration of 24 weeks or longer) based on iRECIST.
6. Duration of Response (DOR) (Time Frame - Up to a maximum of 2 years): DOR is defined as the time from the first documentation of objective response until the first documentation of disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
7. Time to Progression (Time Frame - Up to a maximum of 2 years): Time to progression is defined as the time rom first AMG 305 dose until the first documentation of radiological disease progression by RECIST v1.1 and iRECIST.
8. Progression-Free Survival (PFS) (Time Frame - Up to a maximum of 2 years): PFS is defined as the time from first AMG 305 dose until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
9. Overall Survival (OS) at 1 Year (Time Frame - 1 year)
Experimental: Part A: Dose Exploration Participants will receive escalating doses of AMG 305.
Experimental: Part B: Dose Expansion Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.