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

July 21, 2023 updated by: Onward Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France
        • Recruiting
        • ICM - Montpellier
        • Principal Investigator:
          • Diego Tosi, MD
        • Contact:
      • Montpellier, France
        • Recruiting
        • Saint-Eloi Hospital - Montpellier (CHU)
        • Contact:
        • Principal Investigator:
          • Guillaume Cartron, MD, PhD
      • Paris, France
        • Recruiting
        • Saint-Joseph Hospital - Paris
        • Contact:
          • Sandrine Rullé
          • Phone Number: +33 (0)1 44 12 32 41
          • Email: srulle@ghpsj.fr
        • Principal Investigator:
          • Eric Raymond, MD, PhD
      • Rennes, France
        • Recruiting
        • Centre Eugene Marquis
        • Contact:
        • Principal Investigator:
          • Héloise Bourien, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Histologically or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer
  • Measurable disease
  • Have had all available therapeutic standards for their disease
  • Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
  • ECOG performance status ≤ 1
  • Life expectancy > 3 months as assessed by the investigator
  • Acceptable clinical lab results

Main Exclusion Criteria:

  • Systemic steroids at a daily dose of > 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed
  • Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
  • Within 4 weeks of major surgery
  • Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
  • Prior solid organ transplant
  • Primary or secondary immune deficiency
  • Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
  • Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Clinically significant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OT-A201 monotherapy
OT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.
Drug: OT-A201
OT-A201 IV infusion qw or q2w
Experimental: OT-A201 in combination with iMiD
OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
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
Other Names:
  • lenalidomide
  • pomalidomide
Experimental: OT-A201 in combination with a specific agent
OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
Drug: TBD Compound
Combination regimen for hematological malignancy
Drug: OT-A201
OT-A201 IV infusion qw or q2w
Experimental: OT-A201 in combination with bevacizumab
OT-A201 in combination with bevacizumab at the approved dose
Drug: OT-A201
OT-A201 IV infusion qw or q2w
Drug: Bevacizumab
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
Experimental: OT-A201 in combination with paclitaxel
OT-A201 in combination with paclitaxel at the approved dose
Drug: OT-A201
OT-A201 IV infusion qw or q2w
Drug: Paclitaxel
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
Time Frame: 28 days
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
28 days
Safety profile of OT-A201
Time Frame: 6 months
Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onward Therapeutics

Investigators

  • Principal Investigator: Eric Raymond, MD, PhD, Saint-Joseph Hospital - Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A20101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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