Clinical Trials /

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

NCT04184050

Description:

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: HPN217-3001
  • NCT ID: NCT04184050

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma
  • Multiple Myeloma of Bone
  • Multiple Myeloma With Failed Remission

Interventions

DrugSynonymsArms
HPN217Part 1 (Dose Escalation)

Purpose

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

Trial Arms

NameTypeDescriptionInterventions
Part 1 (Dose Escalation)ExperimentalHPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determine.
  • HPN217
Part 2 (Dose Expansion)ExperimentalHPN217 is IV administered 1x weekly for about 1 hour. Doses will be determined from Part 1 (dose escalation)
  • HPN217

Eligibility 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:

               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)

          3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

          4. Adequate hematologic status, including:

               1. Absolute neutrophil count (ANC) ≥1000 cells/μL

               2. Platelet count ≥50,000/μL (without transfusions)

               3. 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

               1. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct
                  bilirubin

               2. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)

               3. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

        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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assessment of Adverse Events by CTCAE v5.0 of HPN217
Time Frame:4 years
Safety Issue:
Description: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)

Secondary Outcome Measures

Measure:Determine Efficacy by way of Disease Assessment using IMWG Response Criteria
Time Frame:4 years
Safety Issue:
Description:Evaluate preliminary efficacy of HPN217 by way of Disease Assessment using IMWG Response Criteria
Measure:Determine Immunogenicity by way of Anti-drug Antibodies
Time Frame:4 years
Safety Issue:
Description:Evaluate immunogenicity of HPN217 by way of serum anti-drug antibodies being measured at different time points of the study

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Harpoon Therapeutics

Last Updated

March 27, 2020