A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms (NCT05787496) | Clinical Trial Compass
TerminatedPhase 1
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
Stopped: As a result of program reprioritization and due to the limited clinical activity observed in the Phase 1 trial, the study has been discontinued.
United States28 participantsStarted 2023-02-28
Plain-language summary
This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability of NC525. This study will also assess the clinical benefit in subjects with advanced myeloid neoplasms.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subject is willing to provide written informed consent for the trial.
✓. Be ≥ 18 years of age on the day of signing informed consent.
✓. Subject has one of the following Myeloid Neoplasms determined by pathology review at the treating institution:
✓. Relapsed or Refractory AML, Note: Active, relapsed, or refractory AML is defined as any one of the following:
✓. Relapsed or Refractory Myelodysplastic syndrome (MDS) after prior hypomethylating agents.
✓. Relapsed or Refractory Chronic myelomonocytic leukemia (CMML) with progressive disease or lack of response to hypomethylating agents
✓. A male subject must agree to use approved contraception (based on institutional guidelines) and refrain from sperm donation or expecting to father a child, from Screening through the treatment period and for at least 90 days after the last dose of study treatment.
✓. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
✕. Has a diagnosis of acute promyelocytic leukemia (M3, APL), accelerated phase or blast crisis of chronic myeloid leukemia.
✕. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
What they're measuring
1
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
Timeframe: Up to 23 months
2
To Evaluate Dose-limiting Toxicities (DLTs) of NC525.
✕. Patients with active Central Nervous System (CNS) involvement (such as leukemic infiltration, blast in the spinal fluid, or subjects with extramedullary disease).
✕. A WOCBP who has a positive pregnancy test (within 72 hours) prior to treatment.
✕. History or evidence of any other clinically significant disorder, condition or disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic myocardial infection, uncontrolled cardiac arrhythmia, pericardial disease or heart failure New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity and in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures or completion.
✕. Chronic respiratory disease or any other medical condition that requires continuous oxygen that in the opinion of the Investigator, would adversely affect his/her participation in this study.
✕. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
✕. Is currently participating in or has participated in a study of the following prior to the first dose of study treatment: