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

Phase 1

• Conditions: Relapsed/Refractory Multiple Myeloma (RRMM); MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004793-26-FR
• Lead Sponsor: Harpoon Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified