Overview

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

Status:
Recruiting
Trial end date:
2024-06-02
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Harpoon Therapeutics
Criteria
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)