Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)
NCT ID: NCT04184050
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2020-04-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MK-4002 monotherapy dose escalation
MK-4002 is intravenously (IV) administered once weekly in escalating doses.
MK-4002
IV infusion
MK-4002 dose escalation with extended dosing intervals
MK-4002 is IV administered once every 2 weeks.
MK-4002
IV infusion
Interventions
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MK-4002
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response \[MR\] or better) to previous treatment, more than 60 days after cessation of last treatment. Refractory disease defined as \<25% reduction in M protein or progression of disease during treatment or within 60 days after cessation of treatment.
3. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
4. Measurable disease defined as at least one of the following:
1. Serum M-protein ≥0.5 g/dL
2. Urine M-protein ≥200 mg/24 hours
3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
5. Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.
Exclusion Criteria
2. Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the start of study
4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded.
5. History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received any treatment for their autoimmune disorder in the past 3 years
6. Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, in situ cervical cancer, adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years, low-risk prostate cancer with Gleason score \<7 and prostate-specific antigen \<10 ng/mL
18 Years
ALL
No
Sponsors
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Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
The University of Kansas Cancer Center
Fairway, Kansas, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of Rochester James P Wilmot Cancer Institute
Rochester, New York, United States
OHSU
Portland, Oregon, United States
University of Washington - Seattle Cancer Center Alliance
Seattle, Washington, United States
Centre Hospitalier Universitaire De Nantes
Nantes, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Josep Carreras Leukaemia Research Institute
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
Madrid, , Spain
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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U1111-1261-6031
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-4002-001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515582-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004793-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HPN217-3001
Identifier Type: -
Identifier Source: org_study_id
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