Clinical Trial

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

Recruiting Phase 1/2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-08; most recent amendment 2025-12-31.
Status change: Not Yet Recruiting → Recruiting 2025-08-28
Trial Details
NCT Number NCT07124117
Lead Sponsor OBI Pharma, Inc
Conditions Advanced Solid Tumor
Enrollment 147 participants
Start Date 2025-08-04
Primary Completion 2029-02-08 (estimated)
Study Completion 2029-02-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-05