drugset / Trial / NCT05828459

First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

NCT05828459

Phase 1 Recruiting 150 enrolled Onward Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.

Timeline

Start
2023-07-10
Primary completion
2027-01
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject OT-A201 Unknown Intravenous
Background Bevacizumab Monoclonal antibody 10 mg/m2
Background Lenalidomide Other / unclassified 25 mg
Background Paclitaxel Small molecule 175 mg/m2
Background Pomalidomide Other / unclassified 4 mg