Advanced Solid Tumor Clinical Trial
Official title:
A Phase Ia/Ib, Open-Label, Multi-center, First in Human and Expansion Study to Assess the Safety, Tolerance, and Pharmacokinetics of the Novel Antitumor Agent CBP-1008 in Patients With Advanced Solid Tumors
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1008, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, MTD and RP2D. Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. DLT observation period is 28 days. Patients in phase Ib part will be recruited into certain tumor cohorts and receive RP2D CBP-1008 iv infusion every two weeks. Primary efficacy of ORR, DCR, PFS, etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib stage. ;
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