drugset / Trial / NCT06422520

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

NCT06422520

Phase 1 Completed 63 enrolled BeOne Medicines
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-08
Primary completion
2026-05-15
Completion
2026-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject BGB-C354 Unknown Intravenous
Subject Tislelizumab Monoclonal antibody Intravenous

Indications