GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Multiple Myeloma	NCT ID:	NCT04824794
Trial Phases:	Phase I Phase II	Protocol IDs:	GCT3014-01 (primary) NCI-2021-05589
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Genmab
NCI Full Details:	http://clinicaltrials.gov/show/NCT04824794

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. 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.

Objectives

This trial will be conducted in 3 parts: Dose Escalation (phase 1), Expansion Parts, A
and B (phase 2).

In the dose escalation phase GEN3014 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. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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