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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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