NCT07384715RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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: Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 27 Jan 2026
- Start date
- 16 Feb 2026
- Primary completion date
- 18 Oct 2029
- Lead sponsor
- Genmab
- NCT number
- NCT07384715
- EU CT number
- 2025-523101-15-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 78
- From 16 Feb 2026 to the primary completion date, 18 Oct 2029
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.
- Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.
- Other protocol-defined Inclusion and Exclusion criteria may apply.
Other illness
- Active graft-versus-host disease.
- History of severe immune-related adverse events.
Other
- All Participants:
- Diagnosis of acute promyelocytic leukemia (APL).
- Presence of extramedullary AML at screening.
Who the study is looking for
- All Participants:
- Be at least 18 years of age at the time of signing informed consent form (ICF).
- Participant's life expectancy at screening is judged to be at least 3 months.
- Must have fresh bone marrow samples collected at screening.
- Bone marrow (BM) blasts ≥ 5% at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.
- Has acceptable laboratory test results during the screening period
- Participants with R/R AML:
- Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.
- Relapsed or refractory to at least one prior line of therapy.
- Participants with R/R HR-MDS:
- Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).
- Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.