HPN217 for Multiple Myeloma

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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 about the safety of different doses of MK-4002 and how well people tolerate them. Researchers also want to learn what happens to different doses of MK-4002 in a person's body over time.

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.

What makes the drug HPN217 unique for treating multiple myeloma?

The drug HPN217 is unique for treating multiple myeloma because it represents a novel approach compared to traditional treatments, which often involve chemotherapy and stem cell transplants. While specific details about HPN217's mechanism of action or administration are not provided, it is likely being investigated for its potential to target specific pathways or cells involved in multiple myeloma, offering a new therapeutic strategy for this condition. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The independent adverse prognostic significance of 1q21 gain/amplification in newly diagnosed multiple myeloma patients. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Multiple myeloma. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of minimal residual disease and polyclonal plasma cells in myeloma patients achieving a complete response to therapy. [2020]

4. Hungary pubmed.ncbi.nlm.nih.gov

[Therapy of multiple myeloma] [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Targeted therapy of multiple myeloma. [2022]