Clinical Trial

The Efficacy and Safety of IBI363 in Solid Tumors

Study acronym: Promise
Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-10-07; most recent amendment 2024-05-28.
Status change: Not Yet Recruiting → Recruiting 2023-12-25
Trial Details
NCT Number NCT06081907
Lead Sponsor Hunan Province Tumor Hospital
Collaborators: Xiangya Hospital of Central South University
Conditions Advanced Solid Tumor
Enrollment 430 participants
Start Date 2023-12-25
Primary Completion 2026-12-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-05-30