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
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
Drug | Synonyms | Arms |
---|
HPN217 | | Part 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
Name | Type | Description | Interventions |
---|
Part 1 (Dose Escalation) | Experimental | HPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determine. | |
Part 2 (Dose Expansion) | Experimental | HPN217 is IV administered 1x weekly for about 1 hour. Doses will be determined from Part 1 (dose escalation) | |
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
July 28, 2021