Spots Global Cancer Trial Database for A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
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Trial Identification
Brief Title: A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
Official Title: A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
Study ID: NCT04162327
Conditions
Study Description
Brief Summary: 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 IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
Detailed Description: 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, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The 307th Hospital of Chinese People's Liberation Army, Beijing, , China
Contact Details
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