A Phase 1/2a, First-in-human, Open-label, Multicenter, Dose Escalation Study of MP0533 in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT05673057 Phase 1/Phase 2 RECRUITING

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)

Details

Lead sponsor	Molecular Partners AG
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	249
Start date	2022-12-29
Completion	2029-12

Conditions

• Leukemia
• Myeloid
• Acute
• Newly Diagnosed

Interventions

• MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1
• MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A
• MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax
• MP0533 with Obinutuzumab pretreatment
• MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML
• MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients

Primary outcomes

• Phase 1 dose escalation: Recommended Phase 2 Dose Regimen and/or Maximum Tolerated Dose Regimen — from start of treatment to end of first cycle (day 1 - 28)
  Incidence of dose limiting toxicities, assessment of toxicity/safety, pharmacokinetic and efficacy parameters
• Phase 2 dose extension: Overall Response Rate — throughout the study (on average 3 months)
  Best overall response of complete remission (CR), complete remission with partial hematological recovery (CRh), complete remission with incomplete hematological recovery (CRi), morphologic leukemia-free state (MLFS) and partial remission (PR) according to the European LeukemiaNet (ELN) response criteria 2022

Countries

France, Lithuania, Netherlands, Switzerland