drugset / Trial / NCT07124117
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |