GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

Active:	Yes
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. 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.

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 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.

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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