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

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.

Trial Details

NCT ID
NCT05601726
Phase
PHASE1 / PHASE2
Sponsor
Advanced BioDesign
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • ABD-3001
Locations (sample)
  • Marseille, France, France|43.29695,5.38107
  • Paris, France, France|48.85341,2.3488
  • Pierre-Bénite, France, France|45.70359,4.82424

Key Eligibility Criteria

  • Patients with relapsed/refractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligib…
  • Patients with relapsed/refractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk us…
  • Patients not eligible to alloSCT
  • Negative blood or serum/urine pregnancy test

For full eligibility, visit ClinicalTrials.gov.

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