Actively Recruiting
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
Led by Onward Therapeutics · Updated on 2025-03-20
150
Participants Needed
4
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or bone marrow aspiration if recent biopsy was not collected after prior therapy
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months as assessed by the investigator
- Acceptable clinical laboratory results
You will not qualify if you...
- Use of systemic steroids at a daily dose greater than 10 mg of prednisone or equivalent within 28 days before study treatment (transient steroid use for other conditions may be allowed)
- Ongoing immune-related adverse events or adverse events grade 2 or higher from previous therapies not resolved, except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with hormone therapy
- Major surgery within 4 weeks before study treatment
- 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 antibiotics or antiviral treatment
- Seropositive for HIV, hepatitis B virus, or hepatitis C virus except after vaccination or confirmed cure
- Clinically significant disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
ICM - Montpellier
Montpellier, France
Actively Recruiting
2
Saint-Eloi Hospital - Montpellier (CHU)
Montpellier, France
Actively Recruiting
3
Saint-Joseph Hospital - Paris
Paris, France
Actively Recruiting
4
Centre Eugène Marquis
Rennes, France
Actively Recruiting
Research Team
B
Bruno Piccolella
CONTACT
E
Erica Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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