A Phase 1 interventional study of GEN3018 in R/R AML, R/R HR-MDS and Acute Myeloid Leukemia, sponsored by Genmab. Recruiting at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Genmab · Phase 1, Interventional, and Treatment
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.
This is a FIH, Phase 1, open-label, multicenter trial in participants with R/R AML or R/R HR-MDS, to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary anti-tumor activity of GEN3018. The trial will be conducted in 2 parts: Dose Escalation (Part 1) and Dose Refinement (Part 2).
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 78 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Genmab is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 13 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
All Participants:
Participants with R/R AML:
Participants with R/R HR-MDS:
Key Exclusion Criteria:
All Participants:
Other protocol-defined Inclusion and Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive escalating doses of GEN3018 in Part 1 (Dose Escalation). In Part 2 (Dose Refinement), additional participants may be enrolled to evaluate the safety and preliminary efficacy data of the recommended Part 2 dose(s) as determined from the Part 1 Dose Escalation.
Biological: GEN3018
Intravenous (IV) infusion.
Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Parts 1 and 2: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 36 months
Parts 1 and 2: Maximum Concentration (Cmax) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Time to Cmax (tmax) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Predose Trough Concentration (Ctrough) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Sample (AUClast) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Elimination Half-life (t1/2) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Clearance (CL) of GEN3018
Time frame: Cycle 1 and 2 (each cycle is 28 days)
Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GEN3018
Time frame: Up to approximately 1 year
Parts 1 and 2: ORR
Time frame: Up to approximately 1 year
Parts 1 and 2: Duration of Response (DOR)
Time frame: Up to approximately 1 year
Parts 1 and 2: Time to Response (TTR)
Time frame: Up to approximately 1 year
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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