Actively Recruiting
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
Led by Immune System Key Ltd · Updated on 2024-07-10
18
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
I
Immune System Key Ltd
Lead Sponsor
U
University of Miami Sylvester Comprehensive Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined using the body surface area (BSA) measured on Day 1 of each cycle.
CONDITIONS
Official Title
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of relapsed/refractory AML without alternative life-prolonging therapy or adverse genetic risk treatment-naFve patients unlikely to benefit from other therapy
- Confirmed diagnosis of relapsed/refractory MDS with failure or intolerance to hypomethylating agents and intermediate to very high risk disease by IPSS-R
- Adults aged 18 years or older
- ECOG Performance Status of 0, 1, or 2
- Pre-treatment bone marrow expressing ST2 receptor by immunohistochemistry
- Total bilirubin less than 1.5 times upper limit of normal (indirect bilirubin elevation due to post-transfusion hemolysis allowed)
- ALT and AST less than 3 times upper limit of normal
- Creatinine less than 2 times upper limit of normal or creatinine clearance greater than 40 ml/min or eGFR less than 50 by MDRD method
- White blood cell count less than 25,000/uL before first dose of Nerofe
- Use of hydroxyurea allowed to control leukemic blast counts
- Suitable venous access for blood sampling
- Estimated life expectancy to permit at least 8 weeks of treatment
- Voluntary written consent given
- Female patients must be postmenopausal, surgically sterile, or agree to effective contraception or true abstinence during study and for 4 months after last dose
- Male patients must agree to effective barrier contraception or true abstinence during study and for 4 months after last dose
- Able to undergo bone marrow examination at screening
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Absence of ST2 receptor staining on screening bone marrow slide
- Therapy with investigational products, anti-neoplastic therapy, or radiotherapy within 14 days before first dose (hydroxyurea allowed)
- Candidates for standard or curative treatments who are eligible and willing
- Major surgery within 30 days before first dose or scheduled during study
- Grade 2 or higher diarrhea despite supportive care within 7 days before first dose
- Significant cardiopulmonary disease including serious arrhythmias, advanced heart failure, recent myocardial infarction or revascularization, severe valvulopathy, symptomatic pulmonary hypertension, prolonged QTc interval over 480 msec, low left ventricular ejection fraction, or severe COPD/interstitial lung disease
- Active uncontrolled infection or severe infectious disease (stable infections on antibiotics allowed)
- Known HIV positive status
- Known Hepatitis B surface antigen positive without undetectable viral load
- Known or suspected active Hepatitis C infection unless treated with negative viral load
- Females of childbearing potential refusing contraception or abstinence during study and for 4 months after last dose
- Males refusing effective barrier contraception or abstinence during study and for 4 months after last dose
- Lactating or breastfeeding females or positive pregnancy tests during screening
- Females intending to donate eggs or males intending to donate sperm during study or for 4 months after last dose
- Serious medical or psychiatric illness that interferes with study completion
- Symptomatic central nervous system involvement
- Another malignancy diagnosed or treated within 2 years with residual disease
- Known hepatic cirrhosis or severe liver impairment
- Uncontrolled bleeding or coagulopathy
- Use of systemic steroids over 10 mg/day prednisone equivalent within 7 days before first dose
- Active uncontrolled graft versus host disease
- Life-threatening illnesses unrelated to cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Justin Watts, MD
CONTACT
A
Amber Thomassen, APRN-BC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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