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Trial record 1 of 1 for:    DARPIN | AML/MDS
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Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT05673057
Recruitment Status : Recruiting
First Posted : January 6, 2023
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Tracking Information
First Submitted Date  ICMJE December 14, 2022
First Posted Date  ICMJE January 6, 2023
Last Update Posted Date January 24, 2024
Actual Study Start Date  ICMJE December 29, 2022
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2023)
  • 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) ]
    Incidence of dose limiting toxicities, assessment of toxicity/safety, pharmacokinetic and efficacy parameters
  • Phase 2 dose extension: Overall Response Rate [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2023)
  • Serum Concentration-time profiles [ Time Frame: throughout the study (on average 1 year) ]
    Determination of PK parameters including (but not limited to) maximum serum concentration (Cmax)
  • Serum Concentration-time profiles [ Time Frame: throughout the study (on average 1 year) ]
    Determination of PK parameters including (but not limited to) time at Cmax (Tmax)
  • Serum Concentration-time profiles [ Time Frame: throughout the study (on average 1 year) ]
    Determination of PK parameters including (but not limited to) minimal serum concentration (Cmin)
  • Area under the concentration-time curve (AUC) [ Time Frame: throughout the study (on average 1 year) ]
    Pharmacokinetic (PK) analysis of MP0533
  • Total Clearance (CL) [ Time Frame: throughout the study (on average 1 year) ]
    PK analysis of MP0533
  • Volume of distribution (Vd) [ Time Frame: throughout the study (on average 1 year) ]
    PK analysis of MP0533
  • Half-life (t1/2) [ Time Frame: throughout the study (on average 1 year) ]
    PK analysis of MP0533
  • Incidence of adverse events (AEs) as a measure of safety [ Time Frame: throughout the study (on average 1 year) ]
    Type, incidence and severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
  • Event free survival (EFS) [ Time Frame: throughout the study (on average 1 year) ]
    time from the date of first study treatment administration to the date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause
  • Duration of response (DoR) [ Time Frame: throughout the study (on average 1 year) ]
    time from the start date of CR, CRh, CRi, MLFS or PR to relapse or death
  • Overall survival (OS) [ Time Frame: throughout the study (up to 3 years) ]
    time from the date of first study treatment administration to the date of death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Official Title  ICMJE A Phase 1/2a, First-in-human, Open-label, Multicenter, Dose Escalation Study of MP0533 in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Relapsed
  • Myeloid
  • Acute
Intervention  ICMJE Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)

Phase 1 comprises the dose-escalation part of the study and is designed to determine the recommended phase 2a dose regimen (RP2D-R) and/or the maximum tolerated dose-regimen (MTD-R) for MP0533 monotherapy.

Once the RP2D-R or MTD-R has been selected based on the dose escalation part, the study will proceed into the phase 2 expansion part and up to 30 additional patients will be treated.

Other Name: DARPin
Study Arms  ICMJE
  • Experimental: Dose escalation
    Intervention: Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)
  • Experimental: Dose expansion
    Intervention: Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2023)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has signed and dated written informed consent prior to performing any study procedure, including screening
  • Diagnosis of AML or MDS/AML according to the ELN, refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT)
  • Age ≥18 years old on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
  • Anticipated life expectancy ≥ 12 weeks by investigator judgement
  • Adequate renal and hepatic function:
  • Is using highly effective contraception, for females of childbearing potential and for men

Exclusion Criteria:

  • Allogeneic HCT within the last 3 months
  • Active GvHD requiring immune-suppressive therapy
  • Use of immunosuppressive drugs
  • Symptoms of leukostasis (prior hydroxyurea allowed)
  • Clinical signs of AML in the central nervous system
  • Major surgery within 28 days prior to start of study medication
  • Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
  • Any active infection requiring the use of parenteral antimicrobial agents or that is grade >2
  • Treatment with investigational agents and/or agents targeting CD33, CD123 or CD70 within 4 weeks prior to start of trial medication
  • Left ventricular ejection fraction of < 50% on echocardiographic exam at screening
  • History or evidence of clinically significant cardiovascular disease
  • Pulmonary disease with clinically relevant hypoxia
  • Concurrent enrolment in another clinical trial, unless it is an observational (non-interventional) study or it is the follow-up period of an interventional study
  • Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical DirectorG MPAG +41 44 755 77 00 info@molecularpartners.com
Listed Location Countries  ICMJE France,   Lithuania,   Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05673057
Other Study ID Numbers  ICMJE MP0533-CP101
2022-002432-31 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Molecular Partners AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Molecular Partners AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Molecular Partners AG
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP