Phase Ib multicenter study of anti-TIM-3 (S095018/Sym023) in combination with anti-PD-1 (Sym021) in patients with advanced/metastatic recurrent biliary tract cancer - PubMed
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- #Clinical Trial
- #Biliary Tract Cancer
- #Immunotherapy
- Phase Ib study of anti-TIM-3 (S095018) combined with anti-PD-1 (Sym021) in advanced/metastatic biliary tract cancer (BTC).
- Primary endpoints: overall response rate and adverse events incidence/severity.
- Secondary endpoints: pharmacokinetics, immunogenicity, progression-free survival (PFS), and overall survival (OS).
- Results: 5.7% partial response, 31.4% stable disease, median PFS 1.9 months, OS 13.4 months.
- Common adverse events: fatigue, pruritus, infusion-related reactions, increased amylase.
- Biomarker analysis showed increased CD8 T-cell density and upregulated immune-related gene signatures.
- Conclusion: Dual PD-1/TIM-3 inhibition was tolerable but showed modest antitumor activity in BTC patients.