First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients

Recruiting now · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID: NCT05601726
Run by: Advanced BioDesign
People needed: 36
Starts: 2022-11-08
Expected to finish: 2026-12-01
Last updated by the study team: 2025-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Negative blood or serum/urine pregnancy test

You may not qualify if…

Patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF-Beta 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
Ongoing immunosuppressive treatment
Hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1
Active infection requiring intravenous anti-infectious treatment during the screening period
Life-threatening illnesses other than the studied one, 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
Anti-tumor therapy within 14 days of study Visit 1
Prior participation in an interventional investigational clinical study (drug or medical device) within 21 days of study Visit 1
Radiotherapy within 28 days prior to study Visit 1
Current history of seropositivity to human immunodeficiency virus (HIV) or infection with active hepatitis C virus (HCV) or active hepatitis B virus (HBV) or active SARS-CoV-2 (Covid-19) or Syphilis, or Cytomegalovirus (CMV), or Epstein-Barr virus (EBV), or Human T-Lymphotropic Virus (HTLV1)
History of other malignancy in the last 12 months prior to study Visit 1
Other active solid tumor
Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or Left Ventricular Ejection Fraction (LVEF) <50% attested by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days of C1D1 prior to study Visit 1 (Day 1, start of study therapy)
Subjects with a history of myocardial infarction within the last 3 months prior to study Visit 1 (Day 1, start of study therapy)
Subjects with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events
Major surgery within 4 weeks prior to study Visit 1 (Day 1, start of study therapy)
Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial MAD specific exclusion criteria: Patients who have been part of SAD and have experienced a DLT.

Where it is running

Hôpital de la Timone — Marseille, France, France (enrolling)
Hôpital Saint-Louis — Paris, France, France (enrolling)
Centre Hospitalier Lyon Sud — Pierre-Bénite, France, France (enrolling)

Full record on ClinicalTrials.gov

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