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

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.

Timeline

Start

2024-06-12

Primary completion

2027-06

Completion

2027-06

Publications

• Shia CS, Wen SN, Hsu RY, Tu JS, Chang HW, Weng HC, Yang JJ, Chiang MF, Tsao YH, Lu CH, Chen YH, Wu YC, Chen YC, Li WF, Huang TY, Lai MT. Preclinical Pharmacokinetic, Pharmacodynamic, and Safety Profile of OBI-992: A Novel TROP2-Targeted Antibody-Drug Conjugate. Mol Cancer Ther. 2025 Dec 2;24(12):1938-1947. doi: 10.1158/1535-7163.MCT-24-1176.

Drugs

Indications