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Brief Title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Official Title: An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7616789 in Participants With Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Study ID: NCT05619744
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Georgetown Uni Medical Center; Lombardi Cancer Center, Washington, District of Columbia, United States
Massachusetts General Hospital;Oncology, Boston, Massachusetts, United States
Henry Ford Hospital; Josephine Ford Cancer Center, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Medical Center; Division of Hematology-Oncology, Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Rigshospitalet; Fase 1 Enhed - Onkologi, København Ø, , Denmark
National Cancer Center Hospital East; Thoracic Oncology, Chiba, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz, Gda?sk, , Poland
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR