A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? HPN217
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
View:

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

• 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.

• 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).

• Measurable disease defined as at least one of the following:

• Serum M-protein ≥0.5 g/dL

• Urine M-protein ≥200 mg/24 hours

• 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)

• Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.

Locations
United States
Arizona
Banner MD Anderson Cancer Center
Recruiting
Gilbert
Mayo Clinic Arizona
Recruiting
Phoenix
California
UC San Diego Moores Cancer Center
Recruiting
La Jolla
Colorado
Colorado Blood Cancer Institute
Recruiting
Denver
Kansas
The University of Kansas Cancer Center
Recruiting
Fairway
New York
Roswell Park Comprehensive Cancer Center
Recruiting
Buffalo
University of Rochester James P Wilmot Cancer Institute
Recruiting
Rochester
Oregon
OHSU
Recruiting
Portland
Washington
Swedish Cancer Institute
Recruiting
Seattle
University of Washington - Seattle Cancer Center Alliance
Recruiting
Seattle
Other Locations
France
The Centre Hospitalier Universitaire de Lille
Recruiting
Lille
Centre Hospitalier Universitaire De Nantes
Recruiting
Nantes
Centre Hospitalier Universitaire de Poitiers
Recruiting
Poitiers
Germany
Universitatsklinik Tuebingen
Recruiting
Tübingen
Spain
Josep Carreras Leukaemia Research Institute
Recruiting
Barcelona
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
Recruiting
Madrid
Clínica Universidad de Navarra
Recruiting
Pamplona
Hospital Universitario de Salamanca
Recruiting
Salamanca
Contact Information
Primary
Harpoon Therapeutics
hpn217_3001ctgov@harpoontx.com
(650) 452-7280
Time Frame
Start Date: March 1, 2020
Estimated Completion Date: June 2, 2024
Participants
Target number of participants: 70
Treatments
Experimental: Dose Escalation
HPN217 is IV administered 1x weekly for about 1 hour. Doses will vary between cohorts as MTD is being determined.
Authors
Andrew Cowan, Sumit Madan, Jens Hillengass, Raya Mawad, Eva Medvedova, Caitlin Costello, Brea Lipe, Henning Schade, Cyrille Touzeau, Xavier Leleu, Britta Besemer, William Bensigner, Maria-Victoria Mateos Manteca, Leif Bergsegal, Al-Ola Abdallah, Paula Rodriguez Otero, Daniel Morillo, Albert Oriol
Sponsors
Leads: Harpoon Therapeutics

This content was sourced from clinicaltrials.gov

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