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A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Sponsor: BeOne Medicines
Summary
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years. * The study duration is estimated to be approximately 5 years.
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-07-08
Completion Date
2027-01-31
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
BGB-C354
Administered by intravenous infusion
Tislelizumab
Administered by intravenous infusion
Locations (14)
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
Westmead Hospital
Westmead, New South Wales, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China