Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Spain / NCT04184050
Active, not recruiting Phase 1

Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)

NCT04184050 · tracked via the Priya Life Science Spain tracker
Sponsor
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase
Phase 1
Started
2020-04-13
Last updated
2025-12-05

Condition(s) studied

Multiple Myeloma in RelapseMultiple MyelomaMultiple Myeloma of BoneMultiple Myeloma With Failed Remission

Investigational drug(s) / intervention(s)

MK-4002

MK-4002: IV infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Major Inclusion Criteria: 1. Patients ≥18 years of age at the time of signing informed consent 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. Major Exclusion Criteria: 1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma) 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

Primary outcome measure(s)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Up to ~6 years
    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. A TEAE is an adverse event that occurs on or after the first dose of study treatment. The number of participants with TEAEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (American Society for Transplant and Cellular Therapy \[ASTCT\] grading criteria for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]) will be reported.
  • Number of Participants Who Discontinued Study Treatment Due to an AE — Up to ~6 years
    An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE will be reported.
  • Number of Participants with Dose-limiting toxicities (DLT) — Up to 35 days in Cycle 1
    A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the CTCAE 5.0 version for all AEs except CRS and ICANS, which will be graded according to ASTCT. The number of participants who experience a DLT will be reported.
  • Single Dose Maximum Serum Concentration (Cmax) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Cmax of MK-4002 after a single dose.
  • Single Dose Time to Maximum Concentration (Tmax) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Tmax of MK-4002 after a single dose.
  • Area Under the Single Dose Concentration-time Curve Over the Dosing Interval τ (AUCsd,τ) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the AUCsd,τ of MK-4002.
  • Single Dose Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the AUCinf after a single dose of MK-4002.
  • Single Dose Terminal Elimination Half-life (t1/2) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the t1/2 after a single dose of MK-4002.
  • Single Dose Clearance (CL) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the CL after a single dose of MK-4002.
  • Multiple Dose Maximum Concentration at Steady State (Css,max) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Css,max of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Time to Maximum Concentration at Steady State (Tss,max) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Tss,max of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Mutiple Dose Area Under the Steady State Concentration-time Curve Over the Dosing Interval τ (AUCss,τ) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the (AUCss,τ) of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Terminal Elimination Half-life (t1/2) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the t1/2 of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Minimum Concentration at Steady State (Css,min) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Css,min of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Clearance (CL) — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the CL of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Volume of Distribution at Steady State (Vss) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the Vss of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
  • Multiple Dose Accumulation Ratio (AUCss,τ/AUCsd,τ) of MK-4002 — At designated timepoints (up to ~6 years)
    Blood samples collected at designated time points will be used to determine the (AUCss,τ/AUCsd,τ) of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.

Trial sites (12)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Mayo Clinic Arizona Phoenix Arizona
UC San Diego Moores Cancer Center La Jolla California
The University of Kansas Cancer Center Fairway Kansas
Roswell Park Comprehensive Cancer Center Buffalo New York
University of Rochester James P Wilmot Cancer Institute Rochester New York
OHSU Portland Oregon
University of Washington - Seattle Cancer Center Alliance Seattle Washington
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

Other trials for the same condition

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma Active, not recruiting
A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04184050 on ClinicalTrials.gov ↗ ← All trials in Spain