Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome

Sponsor
Molecular Partners AG
Study ID
NCT05673057
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

Key Dates

Start date
Dec 29, 2022
Status verified
Jun 2026
Primary completion
May 29, 2026
Completion
May 31, 2027

Study Design

Enrollment
249 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation (Part 1)
    • MP0533 is administered by intravenous infusion
  • Experimental: Dose escalation (Part 2 - Arm A)
    * MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered
  • Experimental: Dose escalation (Part 2 - Arm B)
    * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional Obinutuzumab pretreatment administered
  • Experimental: Dose expansion (Arm A)
    * MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered
  • Experimental: Dose expansion (Arm B relapsed/refractory AML)
    * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional Obinutuzumab pretreatment administered
  • Experimental: Dose expansion (Arm B in treatment naïve patients)
    * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered

Primary Outcome Measure

Phase 1 dose escalation: Recommended Phase 2 Dose Regimen and/or Maximum Tolerated Dose Regimen [ Time Frame: from start of treatment to end of first cycle (day 1 - 28) ]

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