A Phase 1 interventional study of OT-A201 and IMids in Hematological Malignancy and Solid Tumor, sponsored by Onward Therapeutics. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Onward Therapeutics · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Onward Therapeutics as lead sponsor.
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Main Inclusion Criteria:
Main Exclusion Criteria:
OT-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.
Drug: OT-A201
OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
Drug: OT-A201 · Drug: IMids
OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
Drug: OT-A201 · Drug: TBD Compound
OT-A201 in combination with bevacizumab at the approved dose
Drug: OT-A201 · Drug: Bevacizumab
OT-A201 in combination with paclitaxel at the approved dose
Drug: OT-A201 · Drug: Paclitaxel
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
Also known as: lenalidomide, pomalidomide
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
Maximum 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
Plan to share: No
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