Trial Identifiers
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Scientific Title
A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
Commercial Sponsor
GB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Summary
The STAR CNS trial is a 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumour activity and efficacy of the recommended phase 2 dose of GB5121. GB5121 will be given orally twice per day.