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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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
ICM - Montpellier
Montpellier, France
RECRUITINGSaint-Eloi Hospital - Montpellier (CHU)
Montpellier, France
RECRUITINGSaint-Joseph Hospital - Paris
Paris, France
RECRUITINGCentre Eugène Marquis
Rennes, France
RECRUITINGMaximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
Time frame: 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
Time frame: 6 months
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