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Monoclonal Antibodies

HPN217 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥18 years of age at the time of signing informed consent
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.
Must not have
Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and tolerated by patients with a certain type of cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects of HPN217 are not listed but generally may include typical reactions such as nausea, fatigue, allergic responses to the drug infusion itself and potential impacts on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My multiple myeloma has returned or didn't respond well to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a stem cell or bone marrow transplant less than 3 months ago.
Select...
My condition is either plasma cell leukemia or non-secretory myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Single Dose Concentration-time Curve Over the Dosing Interval τ (AUCsd,τ) of MK-4002
Multiple Dose Accumulation Ratio (AUCss,τ/AUCsd,τ) of MK-4002
Multiple Dose Clearance (CL)
+14 more
Secondary study objectives
Best Overall Response Rate (BOR)
Duration of Response (DOR)
Number of Participants with Anti-drug Antibodies (ADAs) against MK-4002
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MK-4002 monotherapy dose escalationExperimental Treatment1 Intervention
MK-4002 is intravenously (IV) administered once weekly in escalating doses.
Group II: MK-4002 dose escalation with extended dosing intervalsExperimental Treatment1 Intervention
MK-4002 is IV administered once every 2 weeks.

Find a Location

Who is running the clinical trial?

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
3 Previous Clinical Trials
431 Total Patients Enrolled
Harpoon TherapeuticsLead Sponsor
3 Previous Clinical Trials
431 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,369 Total Patients Enrolled
26 Trials studying Multiple Myeloma
4,480 Patients Enrolled for Multiple Myeloma

Media Library

HPN217 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04184050 — Phase 1
Multiple Myeloma Research Study Groups: MK-4002 monotherapy dose escalation, MK-4002 dose escalation with extended dosing intervals
Multiple Myeloma Clinical Trial 2023: HPN217 Highlights & Side Effects. Trial Name: NCT04184050 — Phase 1
HPN217 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04184050 — Phase 1
~10 spots leftby Jun 2025
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