HPN217 for Multiple Myeloma

Not currently recruiting at 18 trial locations

Overseen By Harpoon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Must not be taking: Immunosuppressants

Disqualifiers: Plasma cell leukemia, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-4002 (also known as HPN217) for individuals with multiple myeloma that has returned or did not respond to previous treatments. The trial aims to determine the safety of MK-4002, how individuals tolerate different doses, and how the drug behaves in the body over time. The treatment is administered through an IV, either once a week or every two weeks, to identify the optimal dose. Individuals with multiple myeloma who have tried at least three treatments and still experience symptoms may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medication, you will be excluded from the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that HPN217 holds potential for patients with difficult-to-treat multiple myeloma. Studies found it generally well-tolerated, even at high doses, with most patients experiencing no severe side effects. The treatment led to significant and lasting improvements, providing benefits that endured. Although some side effects were reported, they were usually not serious, suggesting HPN217 is safe for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Researchers are excited about HPN217 for multiple myeloma because it represents a novel approach compared to existing treatments like proteasome inhibitors and immunomodulatory drugs. HPN217 is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T-cells, effectively recruiting the immune system to attack the cancer. This dual-targeting mechanism is different from most standard treatments, offering a potentially more precise and powerful way to combat the disease. Additionally, the unique delivery through intravenous administration might allow for more controlled dosing and potentially fewer side effects.

What evidence suggests that HPN217 might be an effective treatment for multiple myeloma?

Research suggests that HPN217 could help treat relapsed or refractory multiple myeloma (RRMM). Studies have shown that HPN217 targets a protein called BCMA on multiple myeloma cells, aiding the immune system in attacking these cancer cells. In earlier studies, patients who received HPN217 showed signs of the treatment's effectiveness against their cancer. High doses of HPN217 were generally well-tolerated, indicating potential safety for most patients. Although more research is needed, early results are promising for those with RRMM. ^{2 4 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Adults over 18 with relapsed/refractory multiple myeloma who've had at least three prior treatments, including specific inhibitors and antibodies, and have measurable disease. Not for those with plasma cell leukemia, non-secretory myeloma without measurable disease, recent transplants or autoimmune diseases (with some exceptions), or a second primary malignancy not in remission for over 3 years.

Inclusion Criteria

I have recovered from the side effects of my previous treatments.

I've had 3 treatments for myeloma, including specific drugs, and can't tolerate or am not eligible for other beneficial treatments.

You have a certain amount of abnormal proteins in your blood or urine that can be measured.

Exclusion Criteria

I have another cancer besides the one being treated, but it's either in remission for less than 3 years or is a low-risk type.

I had a stem cell or bone marrow transplant less than 3 months ago.

You have an autoimmune disease, except for certain conditions like vitiligo, resolved childhood eczema, or thyroid problems that are under control. If you haven't had treatment for your autoimmune disorder in the past 3 years, you may be able to participate after talking with the study doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-4002 intravenously in escalating doses, administered once weekly or once every 2 weeks

Up to 4 years

Weekly or bi-weekly visits for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HPN217

Trial Overview The trial is testing HPN217's safety, tolerability, and pharmacokinetics (how the drug moves through the body) in patients whose multiple myeloma has returned after treatment or hasn't responded to previous therapies.

How Is the Trial Designed?

Group I: MK-4002 monotherapy dose escalation Experimental Treatment 1 Intervention

MK-4002 is intravenously (IV) administered once weekly in escalating doses.

Group II: MK-4002 dose escalation with extended dosing intervals Experimental Treatment 1 Intervention

MK-4002 is IV administered once every 2 weeks.

Who Is Running the Clinical Trial?

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Lead Sponsor

Trials

4

Recruited

530+

Harpoon Therapeutics

Lead Sponsor

Trials

4

Recruited

530+

Published Research Related to This Trial

Multiple myeloma (MM) is characterized by the malignant growth of B-lymphocytes and is associated with various organ damage due to the production of monoclonal components, leading to complications like renal failure and bone disease.

Current treatments for MM include alkylating agents and glucocorticoids, while bisphosphonates have emerged as an effective option for managing bone disease associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple myeloma. Ascari, E., Merlini, G., Riccardi, A.[2005]

Multiple myeloma (MM) is a complex cancer characterized by genetic abnormalities that affect various oncogenic pathways, making it a challenging disease to treat.

Recent advancements in treatment, including immunomodulatory drugs like thalidomide and lenalidomide, and proteasome inhibitors like bortezomib, have improved patient outcomes, but MM remains incurable for most, highlighting the need for ongoing research into new therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy of multiple myeloma. Dolloff, NG., Talamo, G.[2022]

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1012/502621/Results-from-the-Completed-Dose-Escalation-Portion

Results from the Completed Dose Escalation Portion of the ... This study is designed to assess the safety, pharmacology and early clinical activity of HPN217 using fixed and step-dose (prime dose followed ...

2. onclive.com onclive.com/view/clinical-activity-with-high-dose-hpn217-warrants-continued-research-in-r-r-multiple-myeloma

Clinical Activity With High-dose HPN217 Warrants ... Al-Ola A. Abdallah, MD, discusses updated safety and efficacy data with HPN217 in relapsed/refractory multiple myeloma and next steps for the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123076152

Results from the Completed Dose Escalation Portion of the ... Dose escalation of HPN217, a novel half-life extended BCMA-targeting T-cell engager, has been completed; the MTD was not reached in step dose cohorts.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04184050

Study of HPN217 in Participants With Relapsed/Refractory ... Researchers want to learn if MK-4002 (also known as HPN217) can treat relapsed or refractory multiple myeloma (RRMM). The goals of this study are to learn ...

5. oncdata.com oncdata.com/investigating-the-efficacy-of-hpn217-in-relapsed-refractory-multiple-myeloma-with-luke-walker-md/

Investigating the Efficacy of HPN217 in Relapsed/ ... Dr. Walker delves into the efficacy that HPN217 demonstrated in patients with relapsed/refractory multiple myeloma, including its tolerability and low risk of ...

6. ashpublications.org ashpublications.org/blood/article/140/Supplement%201/7284/487768/Updated-Interim-Results-from-a-Phase-1-Study-of

Updated Interim Results from a Phase 1 Study of HPN217, a ... HPN217 is under investigation in patients with heavily pretreated relapsed/refractory MM (RRMM). Updated, interim results are presented ...

7. ash.confex.com ash.confex.com/ash/2020/webprogram/Paper136012.html

HPN217-3001: A Phase 1/2 Open-Label, Multicenter, Dose ... HPN217-3001 is an ongoing Phase 1/2, open-label, multicenter, global study of the safety, tolerability, and pharmacokinetics of HPN217 in patients with relapsed ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118706265

HPN217-3001: A Phase 1/2 Open-Label, Multicenter, Dose ... HPN217-3001 is an ongoing Phase 1/2, open-label, multicenter, global study of the safety, tolerability, and pharmacokinetics of HPN217 in patients with ...