First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies 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
1 other identifier
interventional
150
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2023
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 20, 2025
March 1, 2025
3.5 years
April 12, 2023
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
28 days
Safety profile of OT-A201
Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations
6 months
Study Arms (5)
OT-A201 monotherapy
EXPERIMENTALOT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.
OT-A201 in combination with iMiD
EXPERIMENTALOT-A201 in combination with lenalidomide or pomalidomide at the approved dose
OT-A201 in combination with a specific agent
EXPERIMENTALOT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
OT-A201 in combination with bevacizumab
EXPERIMENTALOT-A201 in combination with bevacizumab at the approved dose
OT-A201 in combination with paclitaxel
EXPERIMENTALOT-A201 in combination with paclitaxel at the approved dose
Interventions
OT-A201 IV infusion qw or q2w
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
Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
Combination regimen for hematological malignancy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
ICM - Montpellier
Montpellier, France
Saint-Eloi Hospital - Montpellier (CHU)
Montpellier, France
Saint-Joseph Hospital - Paris
Paris, France
Centre Eugène Marquis
Rennes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Raymond, MD, PhD
Saint-Joseph Hospital - Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2023
First Posted
April 25, 2023
Study Start
July 10, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share