GEN3014 for Blood Cancers

No longer recruiting at 74 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: CD38 therapies, Investigational drugs

Disqualifiers: Cardiac disease, CNS tumor, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new antibody treatment, GEN3014, for individuals with certain blood cancers that have returned or are resistant to treatment. The main goals are to assess the safety of GEN3014, determine the appropriate dose, and evaluate its effectiveness. During the trial, different groups will receive either GEN3014 or another drug, daratumumab. Ideal participants are those with multiple myeloma or other blood cancers who have not responded to standard treatments. As a Phase 1 trial, this research aims to understand how GEN3014 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like chemotherapy or investigational drugs shortly before starting the trial, and some medications like corticosteroids have specific limits. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that GEN3014 is a new antibody treatment undergoing its first human trials. Limited information exists on how people respond to it. The study will start with small doses, gradually increasing them while closely monitoring for side effects. These early tests help determine a safe dose for broader use in the future.

As GEN3014 is in the early testing stages, its tolerability in humans remains unknown. There are no approved uses for GEN3014 in humans yet, making this study crucial for assessing its safety. Participants should expect regular check-ups to quickly identify any potential issues. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for blood cancers?

Researchers are excited about GEN3014 because it offers a novel approach to treating certain blood cancers. Unlike most treatments that target surface proteins on cancer cells, GEN3014 uses a unique mechanism to engage the immune system directly, enhancing its ability to attack cancer cells. This treatment could be particularly promising for patients with multiple myeloma (RRMM) who are either new to or resistant to existing therapies like anti-CD38 monoclonal antibodies. By potentially overcoming resistance to current treatments, GEN3014 offers new hope for more effective responses in tough-to-treat cases.

What evidence suggests that GEN3014 might be an effective treatment for blood cancers?

Research has shown that GEN3014 has promising results in early studies. In lab tests, GEN3014 effectively killed cancer cells from multiple myeloma and acute myeloid leukemia. This occurs because GEN3014 is a specially designed antibody that targets CD38, a protein found on many cancer cells. Early data from human studies suggest it is generally safe and shows some effectiveness in patients who haven't been treated with CD38-targeting therapies before. In this trial, some participants will receive GEN3014, while others will receive Daratumumab as an active comparator. Although the treatment remains under study, these initial findings offer hope for its effectiveness against blood cancers like multiple myeloma. ^{1 3 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with certain blood cancers like multiple myeloma or acute myeloid leukemia that have come back or didn't respond to treatment. They should be in a stable condition, not pregnant, and willing to use birth control. People can't join if they've had recent cancer treatments, stem cell transplants, active infections like hepatitis B/C or HIV, central nervous system involvement by the cancer, or are taking other experimental drugs.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test before starting the study treatment. If you are in the Expansion Part B, you need to have a negative pregnancy test within 72 hours before starting the treatment.

I have never received anti-CD38 monoclonal antibodies for my relapsed or refractory multiple myeloma, and I live outside the US.

A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC

Exclusion Criteria

Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B)

I have a serious heart condition.

I have an ongoing or past hepatitis C infection that hasn't been cured.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of GEN3014 to identify a safe dose level

28 days per cycle

Multiple visits per cycle

Expansion Part A

Further evaluation of GEN3014 at the recommended dose in multiple cohorts

Up to 8 years

Expansion Part B

Comparison of GEN3014 IV with daratumumab SC in anti-CD38 mAb-naïve RRMM participants

Up to 8 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 8 years

What Are the Treatments Tested in This Trial?

Interventions

• GEN3014

Trial Overview The trial tests GEN3014 (an antibody) for safety and effectiveness in relapsed/refractory blood cancers. It has three parts: finding a safe dose level (Dose Escalation), testing this dose further (Expansion Part A), and comparing GEN3014 with daratumumab (Expansion Part B). Participants will receive either GEN3014 or daratumumab but no placebos.

How Is the Trial Designed?

Group I: GEN3014 Experimental Treatment 1 Intervention

Experimental: GEN3014 Participants in Dose Escalation phase with * RRMM * R/R AML Participants in Expansion Part A with * RRMM (anti-CD38 mAb-naïve) * RRMM (anti-CD38 mAb-refractory) * R/R DLBCL * R/R AML Participants in Expansion Part B with • RRMM (anti-CD38 mAb-naïve)

Group II: Daratumumab Active Control 1 Intervention

Participants in Expansion Part B with \- RRMM (anti-CD38 mAb-naïve)

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04824794

GEN3014 Trial in Relapsed or Refractory Hematologic ... 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 ...

2. delta.larvol.com delta.larvol.com/Products/?ProductId=e3fb1b7f-5095-4b5c-ae19-4cb26d9068f4

erzotabart (GEN3014) / Genmab Trial completion • Acute Myelogenous Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple ...

3. herdin.ph herdin.ph/index.php/registry?view=research&layout=details&cid=7323

CD38) in Relapsed or Refractory Multiple Myeloma and Other ... Preclinical data have shown: In vitro, GEN3014 has shown superior CDC activity. Efficient tumor cell lysis of multiple myeloma (MM), acute myeloid leukemia (AML) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10320249/

Preclinical anti-tumour activity of HexaBody-CD38, a next- ... HexaBody®-CD38 (GEN3014) is a hexamerization-enhanced human IgG1 that binds CD38 with high affinity. The E430G mutation in its Fc domain ...

5. ash.confex.com ash.confex.com/ash/2023/webprogram/Paper179504.html

4757 GEN3014 (HexaBody ® -CD38) in Anti-CD38 Mab– ... GEN3014 showed a manageable safety profile and clinical activity in anti-CD38 mAb–naive RRMM patients in this expansion cohort.

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT3014-01

GEN3014 Trial in Relapsed or Refractory Hematologic ... 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 ...

7. clinicaltrial.be clinicaltrial.be/fr/details/45709?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

GEN3014 Trial in Relapsed or Refractory Hematologic ... 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 ...

8. qa.georgiacancerinfo.org qa.georgiacancerinfo.org/clinical-trials/detail/5284

GEN3014 Safety Trial in Relapsed or Refractory ... 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 ...