The Efficacy and Safety of IBI363 in Solid Tumors
A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors
Hunan Province Tumor Hospital
430 participants
Dec 25, 2023
INTERVENTIONAL
Conditions
Summary
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.
IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.
IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.
The recommended dosages for IBI363, IBI325, and Lenvatinib in Phase Ib will be determined based on a comprehensive assessment of safety, efficacy, and other data obtained from the safety introduction portions of both Phase Ia (Part A) and Phase Ib (Part B).
Locations(1)
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NCT06081907