Testing OT-A201 for treating blood cancers and solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study evaluates the safety and tolerability of OT-A201 in patients with relapsed or refractory hematological malignancies and advanced solid tumors. The trial includes a dose escalation phase to determine the recommended doses of OT-A201, both as a standalone treatment and in combination with other therapies. Additionally, the study aims to gather preliminary data on the anti-cancer activity of OT-A201. Participants will undergo baseline biopsies if necessary, and their overall health will be monitored throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• ICM - Montpellier
  Montpellier, France Recruiting
• Saint-Eloi Hospital - Montpellier (CHU)
  Montpellier, France Recruiting
• Saint-Joseph Hospital - Paris
  Paris, France Recruiting
• Centre Eugène Marquis
  Rennes, France Recruiting

Study contacts

• Principal investigator: Eric Raymond, MD, PhD — Saint-Joseph Hospital - Paris
• Study coordinator: Bruno Piccolella
• Email: bruno.piccolella@onward-therapeutics.com
• Phone: +33 6 12 97 73 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.