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)
- Conditions
- blood cancerleukemia10024324
- Registration Number
- NL-OMON53857
- Lead Sponsor
- Molecular Partners AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 23
1. Has signed and dated written informed consent prior to performing any study
procedure, including screening
2. Diagnosis of AML or MDS/AML according to the ELN recommendation 2022,
refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with
or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell
transplantation (HCT)
3. Age >=18 years old on the day of signing informed consent
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
5. Anticipated life expectancy >= 12 weeks by investigator judgement
6. Adequate renal and hepatic function:
a. Creatinine clearance > 40 mL/min on the basis of Cockcroft-Gault glomerular
filtration rate estimation, unless considered AML- or MDS-related
b. Serum bilirubin <= 2.5 x upper limit of normal (ULN), unless considered AML-
or MDS-related or due to Gilbert*s syndrome
c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x
ULN, unless considered AML- or MDS-related
7. Is using highly effective contraception, for females of childbearing
potential (FCBP) and for men
1. Allogeneic HCT within the last 3 months
2. Active GvHD requiring immune-suppressive therapy (other than prednisone (or
equivalent) <= 10mg/d)
3. Use of immunosuppressive drugs (other than prednisone (or equivalent) <=10mg/
d) in the past 4 weeks
4. Symptoms of leukostasis (prior hydroxyurea allowed)
5. Clinical signs of AML in the central nervous system
6. Major surgery within 28 days prior to start of study medication
7. Other malignancy requiring active therapy, but adjuvant endocrine therapy is
allowed
8. Any active infection requiring the use of parenteral antimicrobial agents or
that is grade >2
9. Treatment with agents targeting CD33, CD123 or CD70 within 4 weeks prior to
start of trial medication
10. Left ventricular ejection fraction of < 50% on echocardiographic exam at
screening
11. History or evidence of clinically significant cardiovascular disease
12. Pulmonary disease with clinically relevant hypoxia
13. Known Human Immunodeficiency Virus (HIV)-infected patients who are healthy
and have a low risk of Acquired Immunodeficiency Syndrome (AIDS)-related
outcomes may be eligible (see protocol)
14. Active hepatitis B (chronic or acute; HBV)
15. Active hepatitis C (HCV) infection
16. Any vaccines within 28 days before first study drug administration
17. History of another primary malignancy may be excluded (see protocol)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints of this trial are:<br /><br>• Incidence of CRS and non-CRS DLTs during the first cycle of treatment (phase<br /><br>1 only)<br /><br>• Type, incidence and severity of AEs according to National Cancer Institute<br /><br>Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0<br /><br>• Changes in laboratory safety parameters and vital signs<br /><br>• Overall response rate (ORR) based on best overall response of complete<br /><br>remission, complete remission with partial hematological recovery (CRh),<br /><br>complete remission with incomplete hematological recovery (CRi), morphologic<br /><br>leukemia-free state (MLFS) and partial remission (PR) according to the European<br /><br>LeukemiaNet (ELN) response criteria 2022 (phase 2a only)</p><br>
- Secondary Outcome Measures
Name Time Method