A Phase 1/2 Open-label, Multicenter Study to evaluate the safety and tolerability of HPN217 in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004793-26-FR

Enrollment

Registered

2020-04-28

Start date

2020-06-24

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM) MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Product Name: HPN217 Product Code: HPN217 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Not assigned CAS Number: Not assigned Other descriptive name: HPN217 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major Inclusion Criteria 1.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). 2. Measurable disease defined as at least one of the following: a.S erum M-protein =0.5 g/dL b. Urine M-protein =200 mg/24 hours c. Serum free light chain (FLC) assay: Involved FLC level =10 mg/dL (=100 mg/L) 3. Eastern Cooperative Oncology Group (ECOG) performance status =2. 4. Adequate hematologic status, including: a. Absolute neutrophil count (ANC) =1000 cells/µL b. Platelet count =50,000/µL (without transfusions) c. Hemoglobin =8 g/dL 5. Adequate renal function, including: a. Calculated creatinine clearance =30 mL/min using the formula of Cockcroft and Gault 6. Adequate hepatic function, including a. Total bilirubin =1.5 × upper limit of normal (ULN), regardless of direct bilirubin b. AST and ALT =3.0 × ULN (=5.0× ULN if due to myeloma involvement) c. Alkaline phosphatase =3× ULN (=5.0× ULN if due to myeloma involvement) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Major Exclusion Criteria 1.Prior exposure to BCMA-targeting agents (Part 2 only) 2. Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objectives: • Assess safety and tolerability at increasing dose levels of HPN217 in successive cohorts of patients with RRMM • Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D) • Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration;Secondary Objective: Secondary Objectives: • Evaluate preliminary efficacy of HPN217 • Evaluate immunogenicity of HPN217 Exploratory Objective: • Characterize the impact of HPN217 on soluble serum cytokines, including but not limited to interferon gamma (IFN?), interleukin (IL)-6, tumor necrosis factor alpha (TNFa), and peripheral and bone marrow mononuclear cells;Primary end point(s): Primary Endpoints: • Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTCAE version 5.0. • Change from baseline in clinical laboratory parameters, vital signs, and ECGs. • Number and severity of DLTs following treatment with HPN217. • PK parameters of HPN217: o Single dose - maximum concentration (Cmax), time to maximum concentration (Tmax), area under the single dose concentration-time curve over dosing interval t (AUCsd, t), area under the concentration-time curve extrapolated to infinity (AUCinf), terminal elimination half-life (t1/2), and clearance (CL) as data permit o Multiple dose (assuming steady state is achieved) - maximum concentration (Css,max), time to maximum concentration (Tss,max), area under the steady state concentration-time curve over dosing interval t (AUCss, t), t1/2, minimum concentration (Css,min), CL, volume of distribution (Vss), and accumulation ratio (AUCss,t/AUCsd, t) as data permit;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are outlined in Appendix 1 in the protocol Response evaluation is outlined in Appendix 3 in the protocol	—

Measure

Time frame

Main Objective: Primary Objectives: • Assess safety and tolerability at increasing dose levels of HPN217 in successive cohorts of patients with RRMM • Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D) • Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration;Secondary Objective: Secondary Objectives: • Evaluate preliminary efficacy of HPN217 • Evaluate immunogenicity of HPN217 Exploratory Objective: • Characterize the impact of HPN217 on soluble serum cytokines, including but not limited to interferon gamma (IFN?), interleukin (IL)-6, tumor necrosis factor alpha (TNFa), and peripheral and bone marrow mononuclear cells;Primary end point(s): Primary Endpoints: • Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTCAE version 5.0. • Change from baseline in clinical laboratory parameters, vital signs, and ECGs. • Number and severity of DLTs following treatment with HPN217. • PK parameters of HPN217: o Single dose - maximum concentration (Cmax), time to maximum concentration (Tmax), area under the single dose concentration-time curve over dosing interval t (AUCsd, t), area under the concentration-time curve extrapolated to infinity (AUCinf), terminal elimination half-life (t1/2), and clearance (CL) as data permit o Multiple dose (assuming steady state is achieved) - maximum concentration (Css,max), time to maximum concentration (Tss,max), area under the steady state concentration-time curve over dosing interval t (AUCss, t), t1/2, minimum concentration (Css,min), CL, volume of distribution (Vss), and accumulation ratio (AUCss,t/AUCsd, t) as data permit;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are outlined in Appendix 1 in the protocol Response evaluation is outlined in Appendix 3 in the protocol

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints: • Overall response rate (ORR) based on IMWG response criteria • Progression-free survival (PFS) and overall survival (OS) • Duration of response (DOR) • Incidence and titers of ADAs against HPN217;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are outlined in Appendix 1 in the protocol Response evaluation is outlined in Appendix 3 in the protocol	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints: • Overall response rate (ORR) based on IMWG response criteria • Progression-free survival (PFS) and overall survival (OS) • Duration of response (DOR) • Incidence and titers of ADAs against HPN217;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are outlined in Appendix 1 in the protocol Response evaluation is outlined in Appendix 3 in the protocol

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Countries

France, Germany, Spain, United States

Contacts

Public ContactLisa Knapp - Clinical Operations

Harpoon Therapeutics, Inc.

lknapp@harpoontx.com0016504527251

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026