First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

Sponsor
Onward Therapeutics
Study ID
NCT05828459
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematological Malignancy
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OT-A201 — DRUG
    OT-A201 IV infusion qw or q2w
  • IMids — DRUG
    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
  • Bevacizumab — DRUG
    Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w
  • Paclitaxel — DRUG
    Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w
  • TBD Compound — DRUG
    Combination regimen for hematological malignancy

Study Details

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.

Key Dates

First listed
Apr 25, 2023
Start date
Jul 10, 2023
Status verified
Mar 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OT-A201 monotherapy
    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.
  • Experimental: OT-A201 in combination with iMiD
    OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
  • Experimental: OT-A201 in combination with a specific agent
    OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
  • Experimental: OT-A201 in combination with bevacizumab
    OT-A201 in combination with bevacizumab at the approved dose
  • Experimental: OT-A201 in combination with paclitaxel
    OT-A201 in combination with paclitaxel at the approved dose

Primary Outcome Measure

Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201 [ Time Frame: 28 days ]

Central Contacts

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