First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R/R AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R/R HR-MDS). The trial consists of 2 parts: 1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part 2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation. Up to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2). For an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing. All participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby mające co najmniej 18 lat.
- •Oczekiwana długość życia pacjenta to co najmniej 3 miesiące.
- •Próbki szpiku kostnego pobrane podczas kwalifikacji muszą być świeże.
- •Co najmniej 5% komórek blastycznych w szpiku kostnym.
- •Pacjent jest w stanie wykonywać codzienne czynności (stan ogólny dobry).
✗ Disqualifies
- •Zdiagnozowana ostra białaczka promielocytowa.
- •Obecność przerzutów białaczki poza szpikiem kostnym.
- •Przeszczep szpiku kostnego w ciągu ostatnich 3 miesięcy.
- •Aktywna choroba przeszczep przeciwko gospodarzowi.
- •Leczenie przeciwnowotworowe lub duża operacja w ciągu ostatnich 2 tygodni.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
Aarhus Universitetshospital - Skejby
Aarhus, Denmark
Copenhagen Rigshospitalet
Copenhagen, Denmark
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Trial contact
Genmab Trial Information
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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