Institute for Clinical Research Official Portal

GEN3014

Safety Trial in Relapsed or Refractory Hematologic Malignancies

An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Study No: GEN3014 

Study Overview: 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 the 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 a 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

Condition/Disease:

  1. Relapsed or Refractory Multiple Myeloma (RRMM)
  2. Diffuse Large B Cell Lymphoma (DLBCL)
  3. Acute Myeloid Leukemia (AML)

Intervention / Treatment: GEN3014 (Biological), Daratumumab (Drug)

Study Start: 9-3-2021

Enrollment: Ongoing

Study Phase: Expansion Part B (phase 2)

Investigator site:

CCT FIH GEN3014

Sponsor: Genmab 

ICR
National Institutes of Health (NIH)
Ministry of Health Malaysia
Institute For Clinical Research
Block B4, National Institutes of Health (NIH)
No.1, Jalan Setia Murni U13/52, Seksyen U13
40170 Shah Alam, Selangor Darul Ehsan
Malaysia
 
Phone: 603-3362 7700
Email: contact@crc.gov.my
 

NIH Official Portal

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