Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
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

Led by Advanced BioDesign · Updated on 2025-01-20

36

Participants Needed

3

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with relapsed or refractory Acute Myeloid Leukemia (AML) after at least one therapy and salvage treatment, or not eligible for salvage including targeted therapy
  • Adults with relapsed or refractory high-risk or very high-risk Myelodysplastic Syndrome (MDS) not eligible for salvage treatment
  • Patients not eligible for allogeneic stem cell transplantation (alloSCT)
  • Negative pregnancy test in blood, serum, or urine
Not Eligible

You will not qualify if you...

  • AML patients with Inv(16) MYH11-CBF-Beta, t(8;21) AML-ETO RUNX1-RUNX1, or (PML/RARA) karyotype abnormalities eligible for targeted therapies
  • Active or suspected central nervous system leukemia
  • Ongoing immunosuppressive treatment
  • Hematopoietic stem cell transplant within 3 months before study start
  • Active infection requiring intravenous anti-infectious treatment during screening
  • Life-threatening illnesses, uncontrolled medical conditions, or organ dysfunction that could affect safety or study compliance
  • Anti-tumor therapy within 14 days before study start
  • Participation in another interventional trial within 21 days before study start
  • Radiotherapy within 28 days before study start
  • Current infection with HIV, active hepatitis B, C, COVID-19, syphilis, CMV, EBV, or HTLV1
  • History of other malignancy within 12 months prior to study start
  • Other active solid tumors
  • NYHA Class III or IV heart failure or left ventricular ejection fraction less than 50% within 28 days before study start
  • History of myocardial infarction within 3 months before study start
  • QTc interval ≥450 ms or other risk factors for arrhythmia
  • Major surgery within 4 weeks before study start
  • MAD phase exclusion: Participants from SAD who experienced dose-limiting toxicity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hôpital de la Timone

Marseille, France, France, 13005

Actively Recruiting

2

Hôpital Saint-Louis

Paris, France, France, 75475

Actively Recruiting

3

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, France, 69495

Actively Recruiting

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Research Team

G

Guillaume MARTIN

CONTACT

L

Laurent BASSET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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