CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 430 target
Drug / intervention
IBI363 +4 moredrug
Likely dose
IBI363 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06081907
NCT06081907Phase 2RecruitingOn TrackUpdated 25mo ago
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A Prospective, Multi-cohort Study on Efficacy and Safety of IBI363 for Advanced Solid Tumors

Hunan Province Tumor Hospital·interventional·Posted Oct 13, 2023·Updated May 30, 2024

In Brief

A Phase 2 clinical trial evaluating IBI363 for Advanced Solid Tumor. Currently recruiting, targeting 430 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesChina
CollaboratorsXiangya Hospital of Central South University

Timeline

Phase 2Recruiting
20242025202620272028
First PostedOct 13, 2023
Enrollment StartDec 25, 2023
Primary CompletionDec 1, 2026
Study CompletionSep 1, 2028
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 2.7 years agoPrimary completion in 5 months

Interventions

IBI363drug

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

IBI363drug

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

IBI363drug

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

IBI363drug

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

IBI363drug

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).