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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04184050
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Harpoon Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma of Bone, Multiple Myeloma With Failed Remission
Arms & Interventions

Arms

Experimental: Part 1 (Dose Escalation)

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

Experimental: Part 2 (Dose Expansion)

HPN217 is IV administered 1x weekly for about 1 hour. Doses will be determined from Part 1 (dose escalation)

Interventions

Drug: - HPN217

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Banner MD Anderson Cancer Center, Gilbert, Arizona

Status

Recruiting

Address

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Site Contact

Lisa Bismarck, RN, MSN

Lisa.Bismarck@bannerhealth.com

480-256-5463

Mayo Clinic Arizona, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Arizona

Phoenix, Arizona, 85054

Site Contact

Ayodele Adeyemi

adeyemi.ayodele@mayo.edu

480-342-6066

UC San Diego Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Site Contact

Joseph Maroge

jmaroge@health.ucsd.edu

858-246-0682

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Site Contact

James Vick, MHA

James.Vick@SarahCannon.com

720-754-4890

The University of Kansas Cancer Center, Fairway, Kansas

Status

Recruiting

Address

The University of Kansas Cancer Center

Fairway, Kansas, 66205

Site Contact

Leah Miller, MS, CCRP

lmiller25@kumc.edu

913-945-7538

Roswell Park Comprehensive Cancer Center, Buffalo, New York

Status

Recruiting

Address

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Site Contact

ct.gov Contact

askroswell@roswellpark.org

800-767-9355

Rochester, New York

Status

Recruiting

Address

University of Rochester James P Wilmot Cancer Institute

Rochester, New York, 14642

Site Contact

Brea Lipe, MD

brea.lipe@urmc.rochester.edu

585-275-4099

OHSU, Portland, Oregon

Status

Recruiting

Address

OHSU

Portland, Oregon, 97239

Site Contact

Chris Seybold

seyboldc@ohsu.edu

503-494-9298

Swedish Medical Center, Seattle, Washington

Status

Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98104

Site Contact

Krystle Pagarian

krystle.pagarigan@swedish.org

206-386-2098

Seattle, Washington

Status

Recruiting

Address

University of Washington - Seattle Cancer Center Alliance

Seattle, Washington, 98109

Site Contact

Erica Kalista

ekalista@seattlecca.org

206-606-7099

International Sites

Nantes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire De Nantes

Nantes, , 44093

Site Contact

Cyrille Touzeau

Cyrille.TOUZEAU@chu-nantes.fr

+33 2 53 48 24 05

Poitiers, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Poitiers

Poitiers, , 86021

Site Contact

Xavier Leleu, MD

xavier.leleu@chu-poitiers.fr

+33 549 443 717

Universitatsklinik Tuebingen, Tübingen, Germany

Status

Recruiting

Address

Universitatsklinik Tuebingen

Tübingen, , 72076

Clínica Universidad de Navarra, Pamplona, Navarra, Spain

Status

Recruiting

Address

Clínica Universidad de Navarra

Pamplona, Navarra, 31008

Site Contact

Maite San Miguel

msanm.2@unav.es

948 255 400 #2741

Barcelona, Spain

Status

Recruiting

Address

Josep Carreras Leukaemia Research Institute

Barcelona, , 08916

Site Contact

Albert Oriol, MD

aoriol@iconcologia.net

+34934978547 #3973

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

Madrid, , 28040

Site Contact

Daniel Morillo, MD

dmorillo@startmadrid.com

+0034913908922

Hospital Universitario de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hospital Universitario de Salamanca

Salamanca, , 37007

Site Contact

Maria-Victoria Mateos Manteca, MD

mvmateos@usal.es

+340639455880