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

  • Interventional
  • Recruiting
  • NCT04184050
Eligibility Details Visit Clinicaltrials.gov

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

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

Gender
All

Age Group
18 Years to 100 Years

Accepting Healthy Volunteers?
No

Major Inclusion Criteria:

         1. Patients ≥18 years of age at the time of signing informed consent

         2. 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.

         3. 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).

         4. 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) and an abnormal serum FLC ratio (<0.26 or >1.65)

         5. 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:

         1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)

         2. Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.

         3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study

         4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded

         5. Last anticancer treatment within 2 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)

At a Glance

National Government IDNCT04184050

IRB#IRB20-1990

Lead SponsorHarpoon Therapeutics

Lead PhysicianAri Joseph Rosenberg

Collaborator(s)N/A

EligibilityAll
18 Years to 100 Years
Recruiting