01 Apr 2025: OBI has submitted the IND application of a Phase 1/2 human clinical trial for OBI-902 TROP2 ADC to the US FDA
OBI Pharma submitted an Investigational New Drug (IND) application to the US FDA for a Phase 1/2 clinical trial of OBI-902 TROP2 ADC on March 31, 2025
The upcoming Phase 1/2 study will assess safety, pharmacokinetics, and therapeutic effects in patients with advanced solid tumors, with Phase 1 dose escalation expected to complete in 2026, depending on enrolment
OBI-902 is the company’s first antibody-drug conjugate (ADC) developed with its proprietary GlycOBI ADC technology, targeting the TROP2 protein and showing strong antitumor activity in preclinical models