Trial record 1 of 1 for:
DARPIN | AML/MDS
Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
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| ClinicalTrials.gov Identifier: NCT05673057 |
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Recruitment Status :
Recruiting
First Posted : January 6, 2023
Last Update Posted : January 24, 2024
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Sponsor:
Molecular Partners AG
Information provided by (Responsible Party):
Molecular Partners AG
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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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Relapsed Myeloid Acute | Drug: MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | December 29, 2022 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dose escalation |
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 |
| Experimental: Dose expansion |
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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05673057
Contacts
| Contact: Medical DirectorG MPAG | +41 44 755 77 00 | info@molecularpartners.com |
Locations
| France | |
| CHU Bordeaux | Recruiting |
| Bordeaux, France | |
| AP-HP Hôpital Saint-Louis | Recruiting |
| Paris, France, 75010 | |
| IUCT Oncopole | Recruiting |
| Toulouse, France | |
| Lithuania | |
| Vilnius University Hospital Santaros Klinikos | Recruiting |
| Vilnius, Lithuania | |
| Netherlands | |
| Amsterdam UMC - Locatie VUmc | Recruiting |
| Amsterdam, Netherlands | |
| Groningen UMC | Recruiting |
| Groningen, Netherlands | |
| Erasmus MC | Recruiting |
| Rotterdam, Netherlands | |
| Switzerland | |
| Inselspital, Universitaetsspital Bern | Recruiting |
| Bern, Switzerland, 3010 | |
| Universitaetsspital Zuerich | Recruiting |
| Zuerich, Switzerland, 8006 | |
Sponsors and Collaborators
Molecular Partners AG
| Responsible Party: | Molecular Partners AG |
| ClinicalTrials.gov Identifier: | NCT05673057 |
| Other Study ID Numbers: |
MP0533-CP101 2022-002432-31 ( EudraCT Number ) |
| First Posted: | January 6, 2023 Key Record Dates |
| Last Update Posted: | January 24, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Molecular Partners AG:
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DARPin CD33 CD123 |
CD70 T-cell/CD3 engager multispecific |
Additional relevant MeSH terms:
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Leukemia Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Neoplasms by Histologic Type |
Neoplasms Hematologic Diseases Leukemia, Myeloid Bone Marrow Diseases Precancerous Conditions |