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First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
Sponsor: Onward Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-07-10
Completion Date
2027-07
Last Updated
2025-03-20
Healthy Volunteers
No
Conditions
Interventions
OT-A201
OT-A201 IV infusion qw or q2w
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
Bevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
Paclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
TBD Compound
Combination regimen for hematological malignancy
Locations (4)
ICM - Montpellier
Montpellier, France
Saint-Eloi Hospital - Montpellier (CHU)
Montpellier, France
Saint-Joseph Hospital - Paris
Paris, France
Centre Eugène Marquis
Rennes, France