Spots Global Cancer Trial Database for GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies
Official Title: An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Study ID: NCT04824794
Study Description
Brief Summary: 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. Besides 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 or refractory 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 find 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 Part. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 or daratumumab; 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.
Detailed Description: This trial will be conducted in 3 parts: Dose Escalation (phase 1), Expansion Parts, A and B (phase 2). In the dose escalation phase GEN314 will be evaluated in RRMM and relapsed and refractory acute myeloid leukemia (R/R AML). The participants will receive GEN3014 administered at various dose levels in 28 day cycles. Dose Limiting Toxicities (DLTs) will be assessed during the first treatment cycle and the Maximum Tolerated Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be determined. In Expansion Part A, GEN3014 will be further evaluated in 4 cohorts: anti-CD38 monoclonal antibody (mAb)-naive RRMM, anti-CD38 mAb-refractory RRMM, relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), and R/R AML at the RP2D identified from the Dose Escalation per protocol. In Expansion Part B, GEN3014 IV will be compared to daratumumab SC, head-to-head (H2H) to evaluate whether GEN3014 may be more potent in anti-CD38 mAb-naïve RRMM participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John Theurer Cancer Center, Hackensack, New Jersey, United States
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, Nové Město, , 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, Río, , Greece
Ahepa University General hospital, Thessaloníki, , Greece
Szabolcs-Szatmar-Bereg County Hospitals and University Hospital, Josa Andras University Hospital, Nyíregyháza, , Hungary
Chonnam National University Hwasun Hospital, Gwangju, , Korea, Republic of
Pusan National University Hospital PNUH, Pusan, , Korea, Republic of
Gachon University Gil Medical Center, Seongnam, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Hospital Ampang, Ampang, , Malaysia
Hospital Sultanah Aminah, Johor Bahru, , Malaysia
Hospital Umum Sarawak, Kuching, , Malaysia
Beacon Hospital, Petaling Jaya, , Malaysia
Institute of Oncology, ARENSIA Exploratory Medicine, Chisinau, , Moldova, Republic of
Maastricht UMC, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
Auckland Cancer Trials Centre, Grafton, , New Zealand
University Clinic of Hematology, Skopje, , North Macedonia
University Centrum Kliniczne, Gdańsk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Pratia MCM, Kraków, , Poland
Wroclaw Medical University, Wrocław, , Poland
University of Navarra, Pamplona, , Spain
University Hospital of Salamanca, Salamanca, , Spain
Karolinska Institute, Huddinge, , Sweden
Universitetssjukhuset i Lund, Lund, , Sweden
Arensia Exploratory Medicine, Kyiv, , Ukraine
Contact Details
Name: Study Official
Affiliation: Genmab
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
