Solid Tumor Clinical Trial
Official title:
A Phase I, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to test in patients with local advanced/metastatic solid tumors. the main questions it aims to answer are: - to assess the safety and tolerability of BB-1709. - to determine the maximum tolerated dose(MTD) and/or the PR2D of BB-1709
The study consists of two parts: dose-escalation (Phase Ia) and dose expansion (Phase Ib). Phase Ia is a multicenter, open-label, first time in human clinical trial to assess safety, tolerability, pharmacokinetics, immunogenicity, the preliminary anti-tumor activity of BB-1709, and to establish the MTD and/or RP2D of BB-1709 in patients with advanced solid tumors. Phase Ib is to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor. ;
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