NCT07124117

A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-902 in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 147 (estimated)
• Sponsor: OBI Pharma, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Phase 1b (Cohort Expansion) is intended to further characterize the safety and preliminary antitumor activity of the putative RP2D of OBI-902 in selected tumor types. Phase 2 (Randomized Dose Optimization Cohorts) is intended to determine the optimal RP2D of OBI-902 in selected tumor types, before advancing to larger Phase 3 trials.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	OBI-902	OBI-902 is an antibody-drug conjugate study drug

Timeline

• Start date: 2025-08-04
• Primary completion: 2029-02-08
• Completion: 2029-02-08
• First posted: 2025-08-15
• Last updated: 2026-01-05

Locations

6 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study