A Phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti-PD-1) in patients with solid tumors

ASCO 2026Pan-tumorBGB-A3055, TislelizumabPoster

Judith Raimbourg, MD, PhD

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SUMMARY

This Phase 1a doseescalation study evaluated BGBA3055, an investigational humanized monoclonal antibody targeting CC motif chemokine receptor 8 (CCR8), administered as monotherapy (Arm A) or in combination with tislelizumab (Arm B) in patients with advanced or metastatic solid tumors. The primary endpoint was safety, with secondary endpoints including preliminary antitumor activity assessed by RECIST version 1.1. As of November 19, 2025, 98 patients received treatment (Arm A, n=42; Arm B, n=56), with median followup of 3.9 and 4.7 months, respectively. Decreased neutrophil count (23.8%) in Arm A and pyrexia (23.2%) in Arm B were the most common BGBA3055–related treatment-emergent adverse events. Immunemediated enterocolitis was the most common serious adverse event. Doselimiting toxicities occurred in 1 patient receiving monotherapy and 3 receiving combination therapy, and no treatment-related TEAEs leading to death were reported. The unconfirmed objective response rate was 7.5% in Arm A and 18.2% in Arm B, with disease control rates of 35.0% and 56.4%, respectively.

 
ClinicalTrials.gov ID: NCT05935098

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