Actively Recruiting
First-in-human Study to Assess Safety and Dose of OT-A201 Alone and With Other Cancer Drugs in Patients With Selected Blood Cancers and Solid Tumors
Led by Onward Therapeutics · Updated on 2025-03-20
150
Participants Needed
4
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating OT-A201, a bispecific antibody, for its safety and preliminary effectiveness in treating patients with certain blood cancers and solid tumors. This phase 1 study aims to establish safe dosage levels and understand how well patients tolerate the treatment alone and when combined with other approved cancer drugs. The study is sponsored by Onward Therapeutics and focuses on patients with advanced or relapsed cancers who have exhausted standard therapies. Participants may receive OT-A201 through intravenous infusion once a week or every two weeks depending on safety data. The study includes several groups: OT-A201 alone, OT-A201 with immunomodulatory drugs like lenalidomide or pomalidomide, and OT-A201 combined with other treatments such as bevacizumab or paclitaxel. The dose-escalation phase determines the recommended doses, followed by an expansion phase to further explore anti-cancer activity. During the study, participants will undergo various assessments including biopsies or bone marrow aspirations if recent samples are unavailable, regular clinical laboratory tests, and monitoring of side effects. Researchers will evaluate maximum tolerated dose and safety profile over 28 days and up to 6 months. The study involves careful observation to track responses and adverse events, lasting until July 2027.
CONDITIONS
Brief 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 no recent sample exists
- 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 over 10 mg prednisone or equivalent daily within 28 days before study treatment, except brief use for other conditions
- Ongoing immune-related adverse events grade 2 or higher from prior therapies, except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies on hormone therapy
- Major surgery within 4 weeks before study
- History of active autoimmune disorder requiring immunosuppressive therapy in last 12 months
- Prior solid organ transplant
- Primary or secondary immune deficiency
- Active uncontrolled infection needing intravenous antibiotic or antiviral treatment
- Seropositive for HIV, hepatitis B, or hepatitis C except after vaccination or confirmed cure
- Clinically significant disease that could interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive OT-A201 alone or in combination with other cancer drugs by intravenous infusion on a weekly or biweekly schedule, depending on their assigned treatment arm.
Weekly or biweekly visits for IV infusion depending on dosing schedule
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
E
Erica Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here