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

NCT05828459 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Onward Therapeutics

    lead INDUSTRY

Principal Investigators

  • Eric Raymond, MD, PhD · Saint-Joseph Hospital - Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2027-01-31
Completion
2027-07-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828459 on ClinicalTrials.gov