drugset / Trial / NCT07124117

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

NCT07124117 ↗

Phase 1/2 Recruiting 147 enrolled OBI Pharma, Inc
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-08-04
Primary completion
2029-02-08
Completion
2029-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject OBI-902 Unknown 1.6 mg/kg —
Subject OBI-902 Unknown 3 mg/kg —
Subject OBI-902 Unknown 4.5 mg/kg —
Subject OBI-902 Unknown 6 mg/kg —
Subject OBI-902 Unknown 8 mg/kg —
Subject OBI-902 Unknown 10 mg/kg —

Indications