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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05673057
Other study ID # MP0533-CP101
Secondary ID 2022-002432-31
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 29, 2022
Est. completion date December 2027

Study information

Verified date January 2024
Source Molecular Partners AG
Contact Medical DirectorG MPAG
Phone +41 44 755 77 00
Email info@molecularpartners.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Molecular Partners AG

Countries where clinical trial is conducted

France,  Lithuania,  Netherlands,  Switzerland, 

Outcome

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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