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Recruiting NCT05828459

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

Phase I Interventional Hematological Malignancy Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OT-A201, IMids, Bevacizumab, Paclitaxel.
Who it may be relevant to
Registry conditions: Hematological Malignancy, Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201 [Time frame: 28 days]
  • Safety profile of OT-A201 [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 4 centers
  • ICM - Montpellier — Montpellier
  • Saint-Eloi Hospital - Montpellier (CHU) — Montpellier
  • Saint-Joseph Hospital - Paris — Paris
  • Centre Eugène Marquis — Rennes

Identifiers

NCT: NCT05828459 · A20101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗