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Trial record 1 of 1 for:    HPN536
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Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872206
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Harpoon Therapeutics

Brief Summary:
An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.

Condition or disease Intervention/treatment Phase
Advanced Cancers Associated With Mesothelin Expression Biological: HPN536 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression Who Have Failed Standard Available Therapy
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: HPN536-2001 - Fix Dosing Arm

Part 1 (Dose Escalation): will include eligible patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma or malignant mesothelioma. HPN536 will be administered once weekly via IV infusion with a fix dose. Dose escalation per cohort until an estimated therapeutic dose level has been reached.

Part 2 (Dose Expansion):

Group 1: Eligible patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Group 2: Eligible patients with pancreatic adenocarcinoma.

Group 3: Eligible patients with mesothelioma.

Biological: HPN536
Dose escalation: HPN536 will be administered once weekly via IV infusion Dose expansion: HPN536 will be administered at the RP2D once weekly via IV infusion

Experimental: HPN536-2001 - Step Dosing Arm
Part 1 (Dose Escalation): will include eligible patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, pancreatic adenocarcinoma or malignant mesothelioma. HPN536 will be administered once weekly via IV infusion with one or two increasing step dose(s) initially until a target dose as been given. Dose escalation per cohort until an estimated therapeutic dose level has been reached.
Biological: HPN536
Dose escalation: HPN536 will be administered once weekly via IV infusion Dose expansion: HPN536 will be administered at the RP2D once weekly via IV infusion

Experimental: HPN536-2001 - Part 2
Part 2 (Dose Expansion): will include eligible patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, malignant mesothelioma, pancreatic adenocarcinoma or malignant mesothelioma. HPN536 will be administered once weekly via IV infusion.
Biological: HPN536
Dose escalation: HPN536 will be administered once weekly via IV infusion Dose expansion: HPN536 will be administered at the RP2D once weekly via IV infusion




Primary Outcome Measures :
  1. Assess initial safety and determination of recommended Phase 2 dose: Dose limiting toxicity [ Time Frame: 1 year ]
    Dose limiting toxicity measured by adverse events and serious adverse events will be reviewed by dose level by the Safety Oversight Committee and will result in a recommended Phase 2 dose.

  2. Efficacy of HPN536 at the recommended Phase 2 dose: overall response rate (ORR) [ Time Frame: 2 years ]
    Evaluate overall response rate (ORR) as assessed by RECIST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Patients ≥18 years of age
  2. One of the following progressive advanced or metastatic cancers:

    1. Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant
    2. Pancreatic adenocarcinoma (Part 1 and Part 2, Group 2 only) that is locally advanced, and now with progressive disease on or after front-line treatment
    3. Malignant mesothelioma with epithelioid histology, pleural (Part 1 and Part 2, Group 3 only) or primary peritoneal (Part 1 and Part 2, Group 3 only)
  3. For Part 2 only - Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma
  4. Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment
  5. For patients previously treated with systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥2 weeks, or at least 5 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks
  6. ECOG performance status of 0 or 1
  7. Adequate bone marrow function, including:

    1. Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
    2. Platelets ≥100,000/mm3 or ≥100 x 109/L
    3. Hemoglobin (Hgb) ≥10 g/dL
  8. Adequate renal function, including estimated creatinine clearance ≥30 mL/min
  9. Adequate liver function, including:

    1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be <5 mg/dL
    2. Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
  10. Serum albumin as follows:

    1. ≥30 mg/mL for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or mesothelioma
    2. Within normal limits for patients with pancreatic adenocarcinoma
  11. Patients with pancreatic adenocarcinoma: C-reactive protein (CRP) within normal limits

Key Exclusion Criteria:

  1. Previously treated or current brain metastases. Note: Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry and have no evidence of new or enlarging brain metastases
  2. Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening
  3. Patients with pancreatic adenocarcinoma: Any ascites within 1 month prior to screening
  4. History of or known or suspected autoimmune disease
  5. History of clinically significant cardiovascular disease
  6. Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872206


Contacts
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Contact: Harpoon Therapeutics 1-650-689-1047 HPN5362001@harpoontx.com

Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Daniel Ahn, MD    480-342-2000    Ahn.Daniel@Mayo.edu   
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90007
Contact: Lorraine Martinez       Lorraine.Martinez@med.usc.edu   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095-7170
Contact: Lisa Yonemoto    310-794-6500    LYonemoto@mednet.ucla.edu   
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Gerardo Colon-Otero, MD    904-953-2000    Gcolonotero@Mayo.edu   
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Andrea Wahner Hendrickson, MD    507-284-2511    WahnerHendrickson.Andrea@Mayo.edu   
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Casey Ezell    314-273-3899    Casey.ezell@wustl.edu   
United States, Ohio
Cleveland Clinic Taussig Cancer Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Dale Shepard, MD    216-445-5670    TaussigResearch@ccf.org   
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Stephenson Cancer Center    405-271-8778    PhaseI-Referrals@ouhsc.edu   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sheri Mcdougall    215-503-1011      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute         
Contact    1-844-482-4812      
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Mary Crowley Cancer Research    972-566-3000    Referral@MaryCrowley.org   
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Anne Gabel    434-982-6657      
Sponsors and Collaborators
Harpoon Therapeutics
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Responsible Party: Harpoon Therapeutics
ClinicalTrials.gov Identifier: NCT03872206    
Other Study ID Numbers: HPN536-2001
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms