The company Advanced BioDesign is commencing recruitment for the clinical trial of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients.
The conditions are Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes. The trial officially began in France in October 2022 and is planned to complete by December 2024.
This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part followed by a "Regimen optimization" part with an extension cohort.
The population that can be enrolled into this study includes patients with relapsed/refractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligible for salvage treatment regimens including targeted therapy; patients with relapsed/refractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk using Revised International Prognostic Scoring System (IPSS-R) prognostic risk categorization; patients not eligible to alloSCT; all female patients must have negative blood or serum/urine pregnancy test.
Excluded are any patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF or t(8;21) AML-ETO RUNX1-RUNX1 or (PML/RARA) karyotype abnormalities and eligible to targeted therapies; participants with clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia; being on ongoing immunosuppressive treatment; having hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1; having life-threatening illnesses other than the studied one, with uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities; patients on anti-tumor therapy within 14 days of study Visit 1 or with the history of prior participation in an interventional investigational clinical study (drug or medical device) within 21 days of study Visit 1; patients who underwent radiotherapy within 28 days prior to study Visit 1; having history of other malignancy in the last 12 months prior to study Visit; with other active solid tumor; patients taking medications that are known to prolong the QT interval; underwent major surgery within 4 weeks prior to study Visit 1 (Day 1, start of study therapy); having any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05601726.