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RECRUITING
NCT06081907
PHASE1/PHASE2

The Efficacy and Safety of IBI363 in Solid Tumors

Sponsor: Hunan Province Tumor Hospital

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2023-12-25

Completion Date

2028-09-01

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1.5 mg/kg Q3W. IBI325, 20 mg/kg Q3W.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 600 μg/kg Q2W. Lenvatinib, 8mg QD.

DRUG

IBI363

IBI363 is based on the "3+3" model with a dose of 1000 μg/kg Q2W. Lenvatinib, 8mg QD.

DRUG

IBI363

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)

Yongchang Zhang

Changsha, Hunan, China