Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05828459
PHASE1

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

Sponsor: Onward Therapeutics

View on ClinicalTrials.gov

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

Interventions

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

Locations (4)

ICM - Montpellier

Montpellier, France

Saint-Eloi Hospital - Montpellier (CHU)

Montpellier, France

Saint-Joseph Hospital - Paris

Paris, France

Centre Eugène Marquis

Rennes, France