A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM
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ClinicalTrials.gov Identifier: NCT04184050 |
Recruitment Status :
Recruiting
First Posted : December 3, 2019
Last Update Posted : March 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma in Relapse Multiple Myeloma Multiple Myeloma of Bone Multiple Myeloma With Failed Remission | Drug: HPN217 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 114 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma |
Actual Study Start Date : | March 1, 2020 |
Estimated Primary Completion Date : | January 2, 2024 |
Estimated Study Completion Date : | June 2, 2024 |

Arm | Intervention/treatment |
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Experimental: Part 1 (Dose Escalation)
HPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determined.
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Drug: HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains |
Experimental: Part 2 (Dose Expansion)
HPN217 is IV administered 1x weekly for about 1 hour. Doses will be determined from Part 1 (dose escalation)
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Drug: HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains |
- Assessment of Adverse Events by CTCAE v5.0 of HPN217 [ Time Frame: 4 years ]Assess safety and tolerability at increasing dose levels of HPN217 in successive cohorts of patients with RRMM by way of adverse events (CTCAE v5.0)
- Determine MTD/ RP2D [ Time Frame: 2 years ]Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)
- Characterize Pharmacokinetics of Serum levels of HPN217 [ Time Frame: 2 years ]Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration
- Determine Efficacy by way of Disease Assessment using IMWG Response Criteria [ Time Frame: 4 years ]Evaluate preliminary efficacy of HPN217 by way of Disease Assessment using IMWG Response Criteria
- Determine Immunogenicity by way of Anti-drug Antibodies [ Time Frame: 4 years ]Evaluate immunogenicity of HPN217 by way of serum anti-drug antibodies being measured at different time points of the study

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
- 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.
- 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).
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Measurable disease defined as at least one of the following:
- Serum M-protein ≥0.5 g/dL
- Urine M-protein ≥200 mg/24 hours
- 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)
- 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:
- Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
- Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
- Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
- Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded
- Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184050
Contact: Harpoon Therapeutics | (650) 452-7280 | hpn217_3001ctgov@harpoontx.com |

Responsible Party: | Harpoon Therapeutics |
ClinicalTrials.gov Identifier: | NCT04184050 |
Other Study ID Numbers: |
HPN217-3001 |
First Posted: | December 3, 2019 Key Record Dates |
Last Update Posted: | March 4, 2022 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |