NCT06422520

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BGB-C354	Administered by intravenous infusion
DRUG	Tislelizumab	Administered by intravenous infusion

Timeline

• Start date: 2024-07-08
• Primary completion: 2026-12-01
• Completion: 2027-01-31
• First posted: 2024-05-21
• Last updated: 2026-04-06

Locations

14 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study