Clinical Trial

A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Part B (Cohort Expansion) is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-24; most recent amendment 2025-08-06.
Status change: Recruiting → Active, Not Recruiting 2025-08-06
Trial Details
NCT Number NCT06480240
Lead Sponsor OBI Pharma, Inc
Conditions Advanced Solid Tumor
Enrollment 117 participants
Start Date 2024-06-12
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-08