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. 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). 2. 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) 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 4. Adequate hematologic status, including: 1. Absolute neutrophil count (ANC) ≥1000 cells/μL. 2. Platelet count ≥50,000/μL (without transfusions) 3. Hemoglobin ≥8 g/dL. 5. Adequate renal function, including: a. Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault. 6. Adequate hepatic function, including. 1. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin. 2. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement) 3. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement) Major

Exclusion Criteria:

1. Prior exposure to BCMA-targeting agents (Part 2 only) 2. Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening

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 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 determine.

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

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

Stephanie Short

stephanie_short@urmc.rochester.edu

585-276-7885

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

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

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

Madrid, , 28040

Site Contact

Daniel Morillo, Dr.

dmorillo@startmadrid.com

+0034913908922