RecruitingPhase 1NCT05828459

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


Sponsor

Onward Therapeutics

Enrollment

150 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called IMids, and others for people with hematological malignancy and solid tumor. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOT-A201

OT-A201 IV infusion qw or q2w

DRUGIMids

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

DRUGBevacizumab

Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w

DRUGPaclitaxel

Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w

DRUGTBD 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

View Full Details on ClinicalTrials.gov

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NCT05828459


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