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Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started2026-03-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 12 → 11 primary endpoints
See other at-risk trials from Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Amendment history

2026-07-21
Study Status, Outcome Measures, Contacts/Locations v1
Primary endpoint(s) modified12 to 11 entries
WasDose limiting toxicities (DLTs), Number of AEs leading to dose delay, Number of AEs leading to dose reduction, Number of AEs leading to permanent discontinuation, Number of AEs（adverse events） leading to dose interruption, Number of subjects with clinically significant changes in electrocardiogram, Number of subjects with clinically significant changes in laboratory parameters, Number of subjects with clinically significant changes in physical examination results, Number of subjects with clinically significant changes in vital signs, Numbers of subjects with adverse events, Numbers of subjects with serious adverse events, Objective response rate (ORR) in dose expansion
NowDose limiting toxicities (DLTs), Number of AEs leading to dose reduction, Number of AEs leading to permanent discontinuation, Number of AEs（adverse events） leading to dose interruption, Number of subjects with clinically significant changes in electrocardiogram, Number of subjects with clinically significant changes in laboratory parameters, Number of subjects with clinically significant changes in physical examination results, Number of subjects with clinically significant changes in vital signs, Numbers of subjects with adverse events, Numbers of subjects with serious adverse events, Objective response rate (ORR) in dose expansion
2026-05-11
Original filing
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
Trial Details
NCT Number NCT07589205
Lead Sponsor Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Conditions Solid Tumor, Colorectal Cancer, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Head and Neck Squamous Cell Carcinoma
Enrollment 493 participants
Start Date 2026-03-31
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-23