NCT05828459

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

A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 as Monotherapy and in Combination Therapy in Patients With Selected Hematological Malignancies and Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Onward Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Malignancy
• Solid Tumor

Interventions

Type	Name	Description
DRUG	OT-A201	OT-A201 IV infusion qw or q2w
DRUG	IMids	Combination regimen for hematological malignancy Lenalidomide: 25 mg on Days 1 to 21 of each 28-day cycle; or Pomalidomide: 4 mg on Days 1 to 21 of each 28-day cycle
DRUG	Bevacizumab	Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
DRUG	Paclitaxel	Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
DRUG	TBD Compound	Combination regimen for hematological malignancy

Timeline

• Start date: 2023-07-10
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2023-04-25
• Last updated: 2025-03-20

Locations

4 sites across 1 country: France