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Brief Title: A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
Official Title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
Study ID: NCT05935098
Brief Summary: This study aims to test the safety, tolerability, and preliminary anti-tumor activity of BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.
Detailed Description: The primary objective of the study is to assess the safety and tolerability of BGB-A3055 alone or in combination with Tislelizumab during dose escalation and to determine the recommended dose for expansion. During dose expansion, the primary objective will be to assess preliminary anti-tumor activity and further characterize the safety of the recommended dose for expansion. . Around 318 participants will be enrolled in this study, and they will be assigned to different treatment groups. Both the participants and their doctors will be aware of which treatment group they are assigned to throughout the study. The treatments, BGB-A3055 alone or in combination with Tislelizumab, will be administered intravenously to evaluate their safety and determine the highest dose that can be tolerated by participants. The study will be conducted at multiple medical centers worldwide. The expected duration of participation in this study is two years. Treatment will continue until participants no longer receive any benefits from the drugs, experience excessive side effects, or decide to withdraw their consent.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
John Theurer Cancer Center Hackensack University Medical Center, Hackensack, New Jersey, United States
Next Dallas, Irving, Texas, United States
Chris Obrien Lifehouse, Camperdown, New South Wales, Australia
Icon Cancer Care South Brisbane, South Brisbane, Queensland, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Centre de Lutte Contre Le Cancer Institut Bergonie, Bordeaux, , France
Institut Curie, Paris, , France
Ico Site Rene Gauducheau, SaintHerblain, , France
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR