JOURNAL ONKOLOGIE – STUDIE

Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05673057

Studienbeginn:
Dezember 2022

Letztes Update:
24.01.2024

Wirkstoff:
MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70)

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Molecular Partners AG

Collaborator:
-

Kontakt

Medical DirectorG MPAG
Kontakt:
Phone: +41 44 755 77 00
E-Mail: info@molecularpartners.com» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

CHU Bordeaux
Bordeaux
FranceRekrutierend» Google-Maps

AP-HP Hôpital Saint-Louis
75010 Paris
FranceRekrutierend» Google-Maps

IUCT Oncopole
Toulouse
FranceRekrutierend» Google-Maps

Vilnius University Hospital Santaros Klinikos
Vilnius
LithuaniaRekrutierend» Google-Maps

Amsterdam UMC - Locatie VUmc
Amsterdam
NetherlandsRekrutierend» Google-Maps

Groningen UMC
Groningen
NetherlandsRekrutierend» Google-Maps

Erasmus MC
Rotterdam
NetherlandsRekrutierend» Google-Maps

Inselspital, Universitaetsspital Bern
3010 Bern
SwitzerlandRekrutierend» Google-Maps

Universitaetsspital Zuerich
8006 Zuerich
SwitzerlandRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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

2. 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

Secondary outcome:

1. 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)

2. 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)

3. 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)

4. Area under the concentration-time curve (AUC) (Time Frame - throughout the study (on average 1 year)):
Pharmacokinetic (PK) analysis of MP0533

5. Total Clearance (CL) (Time Frame - throughout the study (on average 1 year)):
PK analysis of MP0533

6. Volume of distribution (Vd) (Time Frame - throughout the study (on average 1 year)):
PK analysis of MP0533

7. Half-life (t1/2) (Time Frame - throughout the study (on average 1 year)):
PK analysis of MP0533

8. 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

9. 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

10. 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

11. 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

Studien-Arme

Experimental: Dose escalation
Experimental: Dose expansion

Geprüfte Regime

MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) (DARPin):
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.

Quelle: ClinicalTrials.gov

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