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ACTIVE NOT RECRUITING
NCT06422520
PHASE1

A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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

Interventions

DRUG

BGB-C354

Administered by intravenous infusion

DRUG

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