A Phase I First-in-Human Study to Evaluate the Safety and Pharmacokinetics of GEN3018 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

The primary objective of this first-in-human study is to evaluate the safety and tolerability of GEN3018 in patients diagnosed with relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome. This investigation is clinically significant for establishing the initial safety profile and determining the maximum tolerated dose of the investigational agent in advanced hematologic malignancies. Safety and efficacy are the central focus areas of this clinical evaluation.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients experiencing relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome. The cohort includes both male and female individuals, including vulnerable populations. The age range corresponds to the specified pediatric and adult classifications.

This Phase 1, first-in-human clinical trial is designed to evaluate the safety and pharmacology of GEN3018 in patients with relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome. The study follows a systematic methodology involving several stages of assessment. The process begins with a screening visit to determine eligibility based on predefined criteria. Following inclusion, participants will attend scheduled follow-up visits to monitor clinical responses and safety parameters. The study concludes with an end-of-study visit. The total duration of the study is estimated to span from February 2026 to October 2027. Early termination of participation may occur if specific clinical conditions or safety protocols necessitate discontinuation.

The assessment of efficacy in this study focuses on patients with relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome.