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A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM

Sponsor
Harpoon Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04184050
Collaborator
(none)
70
Enrollment
18
Locations
1
Arm
51.1
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jan 2, 2024
Anticipated Study Completion Date :
Jun 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation

HPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determined.

Drug: HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains

Outcome Measures

Primary Outcome Measures

  1. Assessment of Adverse Events by CTCAE v5.0 of HPN217 [4 years]

    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)

  2. Determine MTD/ RP2D [2 years]

    Estimate the maximum tolerated dose (MTD) or select the recommended Phase 2 dose (RP2D)

  3. Characterize Pharmacokinetics of Serum levels of HPN217 [2 years]

    Characterize single dose and multiple dose pharmacokinetics (PK) of HPN217 following intravenous (IV) administration

Secondary Outcome Measures

  1. Determine Efficacy by way of Disease Assessment using IMWG Response Criteria [4 years]

    Evaluate preliminary efficacy of HPN217 by way of Disease Assessment using IMWG Response Criteria

  2. Determine Immunogenicity by way of Anti-drug Antibodies [4 years]

    Evaluate immunogenicity of HPN217 by way of serum anti-drug antibodies being measured at different time points of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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:

  5. Serum M-protein ≥0.5 g/dL

  6. Urine M-protein ≥200 mg/24 hours

  7. 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)

  8. 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. History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received any treatment for their autoimmune disorder in the past 3 years

  6. Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, in situ cervical cancer, adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years, low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 ng/mL

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
2 Mayo Clinic Arizona Phoenix Arizona United States 85054
3 UC San Diego Moores Cancer Center La Jolla California United States 92093
4 Colorado Blood Cancer Institute Denver Colorado United States 80218
5 The University of Kansas Cancer Center Fairway Kansas United States 66205
6 Roswell Park Comprehensive Cancer Center Buffalo New York United States 14263
7 University of Rochester James P Wilmot Cancer Institute Rochester New York United States 14642
8 OHSU Portland Oregon United States 97239
9 Swedish Cancer Institute Seattle Washington United States 98104
10 University of Washington - Seattle Cancer Center Alliance Seattle Washington United States 98109
11 The Centre Hospitalier Universitaire de Lille Lille France 59000
12 Centre Hospitalier Universitaire De Nantes Nantes France 44093
13 Centre Hospitalier Universitaire de Poitiers Poitiers France 86021
14 Universitatsklinik Tuebingen Tübingen Germany 72076
15 Clínica Universidad de Navarra Pamplona Navarra Spain 31008
16 Josep Carreras Leukaemia Research Institute Barcelona Spain 08916
17 Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Madrid Spain 28040
18 Hospital Universitario de Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • Harpoon Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harpoon Therapeutics
ClinicalTrials.gov Identifier:
NCT04184050
Other Study ID Numbers:
  • HPN217-3001
First Posted:
Dec 3, 2019
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 25, 2022