Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically 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 * Determine the recommended phase 2 dose (RP2D)
Key facts
- Study ID
- NCT05800964
- Run by
- Amgen
- People needed
- 37
- Starts
- 2023-06-13
- Expected to finish
- 2026-01-22
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- New York University Cancer Institute — New York, New York, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Next Oncology — San Antonio, Texas, United States
- Chris OBrien Lifehouse — Camperdown, New South Wales, Australia
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France
- Gustave Roussy — Villejuif, France
- Universitaetsklinikum Dresden — Dresden, Germany
- Universitaetsklinikum Essen — Essen, Germany
- Universitaetsklinikum Wuerzburg — Würzburg, Germany
- National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain
- Hospital Clinic i Provincial de Barcelona — Barcelona, Catalonia, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Universitario Madrid Sanchinarro — Madrid, Spain
- Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom
- Sarah Cannon Research Institute UK — London, United Kingdom
- University College London Hospital — London, United Kingdom
- Christie Hospital — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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