Testing OT-A201 for treating blood cancers and solid tumors
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 study is testing a new treatment called OT-A201 to see if it can safely help people with blood cancers and solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Onward Therapeutics Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 4 sites (Montpellier and 3 other locations) |
| Trial ID | NCT05828459 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with confirmed relapsed or refractory hematological malignancies or advanced solid tumors who have exhausted standard treatment options.
Not a fit: Patients currently receiving systemic steroids above a certain threshold or those with unresolved severe adverse events from previous therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat cancers.
How similar studies have performed: Other studies have shown promise with similar investigational therapies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.