GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies
Stopped early · Phase 1/Phase 2
Conditions studied: Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B Cell Lymphoma (DLBCL), Acute Myeloid Leukemia (AML)
In brief
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed (disease has returned) or refractory (resistant to treatment) multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: 1. The Dose Escalation will test increasing doses of GEN3014 to identify a safe dose level to be tested in the other two parts. 2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 into the vein or daratumumab under the skin; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.
Key facts
- Study ID
- NCT04824794
- Run by
- Genmab
- People needed
- 130
- Starts
- 2021-03-09
- Expected to finish
- 2025-07-31
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Medical college of Wisconsin — Milwaukee, Wisconsin, United States
- Northern Health — Epping, Australia
- The Alfred Hospital — Melbourne, Australia
- Royal Prince Alfred Hospital — Sydney, Australia
- University Clinical Center of the Republic of the Srpska — Banja Luka, Bosnia and Herzegovina
- Klinika za hematologiju KCUS — Sarajevo, Bosnia and Herzegovina
- UKC - University Clinical Center Tuzla — Tuzla, Bosnia and Herzegovina
- Fakultni Nemocnice Brno — Brno, Czechia
- Vseobecna fakultni nemocnice — New Town, Czechia
- Fakultni Nemocnice Hradec Kralove FNHK — Nový Hradec Králové, Czechia
- Fakultni Nemocnice Olomouc (FNOL) — Olomouc, Czechia
- FNO - Fakultni nemocnice Ostrava — Poruba, Czechia
- Aalborg Universitet — Aalborg, Denmark
- Vejle Hospital — Vejle, Denmark
- CHRU de Lille — Lille, France
- CHRU de Nantes — Nantes, France
- ARENSIA Exploratory Medicine LLC — Tbilisi, Georgia
- Alexandra General Hospital — Athens, Greece
- Evangelismos Hospital NKUA — Athens, Greece
- University General Hospital of Patras — Rio, Greece
- Ahepa University General hospital — Thessaloniki, Greece
- Szabolcs-Szatmar-Bereg County Hospitals and University Hospital, Josa Andras University Hospital — Nyíregyháza, Hungary
- Hospital Ampang — Ampang, Malaysia
- John Theurer Cancer Center — Hackensack, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.