OncoMatch/Clinical Trials/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
Is NCT05601726 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ABD-3001 and ABD-3001 for acute myeloid leukemia, adult.
Treatment: ABD-3001 · ABD-3001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Excluded: MYH11 Inv(16)
AML with Inv(16) MYH11-CBF-Beta
Excluded: RUNX1 t(8;21) AML-ETO RUNX1-RUNX1
t(8;21) AML-ETO RUNX1-RUNX1
Excluded: PML PML/RARA karyotype abnormalities
PML/RARA karyotype abnormalities and eligible to targeted therapies
Excluded: RARA PML/RARA karyotype abnormalities
PML/RARA karyotype abnormalities and eligible to targeted therapies
Prior therapy
Must have received: salvage treatment
after failing at least one therapy regimen and a salvage treatment or are not eligible for salvage treatment regimens including targeted therapy
Cannot have received: hematopoietic stem cell transplantation
Exception: performed within 3 months prior to study Visit 1
Hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1
Cannot have received: anti-tumor therapy
Exception: within 14 days of study Visit 1
Anti-tumor therapy within 14 days of study Visit 1
Cannot have received: radiotherapy
Exception: within 28 days prior to study Visit 1
Radiotherapy within 28 days prior to study Visit 1
Cannot have received: interventional investigational clinical study (drug or medical device)
Exception: within 21 days of study Visit 1
Prior participation in an interventional investigational clinical study (drug or medical device) within 21 days of study Visit 1
Lab requirements
Cardiac function
NYHA Class III or IV congestive heart failure or LVEF <50% by ECHO or MUGA within 28 days of C1D1; history of myocardial infarction within last 3 months; QTc ≥450 ms or other factors increasing risk of QT prolongation or arrhythmic events
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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