Leukemia Clinical Trial
Official title:
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)
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)
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Bordeaux | Bordeaux | |
France | AP-HP Hôpital Saint-Louis | Paris | |
France | IUCT Oncopole | Toulouse | |
Lithuania | Vilnius University Hospital Santaros Klinikos | Vilnius | |
Netherlands | Amsterdam UMC - Locatie VUmc | Amsterdam | |
Netherlands | Groningen UMC | Groningen | |
Netherlands | Erasmus MC | Rotterdam | |
Switzerland | Inselspital, Universitaetsspital Bern | Bern | |
Switzerland | Universitaetsspital Zuerich | Zuerich |
Lead Sponsor | Collaborator |
---|---|
Molecular Partners AG |
France, Lithuania, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1 dose escalation: Recommended Phase 2 Dose Regimen and/or Maximum Tolerated Dose Regimen | Incidence of dose limiting toxicities, assessment of toxicity/safety, pharmacokinetic and efficacy parameters | from start of treatment to end of first cycle (day 1 - 28) | |
Primary | Phase 2 dose extension: Overall Response Rate | 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 | throughout the study (on average 3 months) | |
Secondary | Serum Concentration-time profiles | Determination of PK parameters including (but not limited to) maximum serum concentration (Cmax) | throughout the study (on average 1 year) | |
Secondary | Serum Concentration-time profiles | Determination of PK parameters including (but not limited to) time at Cmax (Tmax) | throughout the study (on average 1 year) | |
Secondary | Serum Concentration-time profiles | Determination of PK parameters including (but not limited to) minimal serum concentration (Cmin) | throughout the study (on average 1 year) | |
Secondary | Area under the concentration-time curve (AUC) | Pharmacokinetic (PK) analysis of MP0533 | throughout the study (on average 1 year) | |
Secondary | Total Clearance (CL) | PK analysis of MP0533 | throughout the study (on average 1 year) | |
Secondary | Volume of distribution (Vd) | PK analysis of MP0533 | throughout the study (on average 1 year) | |
Secondary | Half-life (t1/2) | PK analysis of MP0533 | throughout the study (on average 1 year) | |
Secondary | Incidence of adverse events (AEs) as a measure of safety | Type, incidence and severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | throughout the study (on average 1 year) | |
Secondary | Event free survival (EFS) | 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 | throughout the study (on average 1 year) | |
Secondary | Duration of response (DoR) | time from the start date of CR, CRh, CRi, MLFS or PR to relapse or death | throughout the study (on average 1 year) | |
Secondary | Overall survival (OS) | time from the date of first study treatment administration to the date of death | throughout the study (up to 3 years) |
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