NCT05601726 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
| NCT ID | NCT05601726 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Advanced BioDesign |
| Condition | Acute Myeloid Leukemia, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2022-11-08 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Laurent BASSET
STUDY DIRECTOR
Advanced BioDesign
Frequently Asked Questions
Who can join the NCT05601726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05601726 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05601726 currently recruiting?
Yes, NCT05601726 is actively recruiting participants. Contact the research team at guillaume.martin@a-biodesign.com for enrollment information.
Where is the NCT05601726 trial being conducted?
This trial is being conducted at Marseille, France, Paris, France, Pierre-Bénite, France.
Who is sponsoring the NCT05601726 clinical trial?
NCT05601726 is sponsored by Advanced BioDesign. The principal investigator is Laurent BASSET at Advanced BioDesign. The trial plans to enroll 36 participants.
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