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Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

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ClinicalTrials.gov Identifier: NCT03872206
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : April 18, 2019
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
Intervention Model: Single Group 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: Experimental: HPN536-2001

Part 1 (Dose Escalation): will include eligible patients with ovarian cancer. HPN536 will be administered once weekly via IV infusion with dose escalation until an estimated therapeutic dose level has been reached.

Part 2 (Dose Expansion) will include treatment of the following disease groups:

  • Group 1: Eligible patients with ovarian cancer. Patients in this group will receive HPN536 at the RP2D established in Part 1.
  • Group 2: Eligible patients with pancreatic carcinoma. The first 3 patients will receive HPN536 at dose that is lower than the RP2D established in Part 1. Additional patients will be enrolled at different dose levels, depending on how the dose is tolerated.
  • Group 3: Eligible patients with mesothelioma. The first 3 patients will receive HPN536 at dose that is lower than the recommended RP2D established in Part 1. Additional patients will be enrolled at different dose levels, depending on how the dose is tolerated.
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



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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

Key Inclusion Criteria:

  1. Patients ≥18 years of age
  2. One of the following progressive advanced or metastatic cancers:

    1. Ovarian cancer (Part 1 and Part 2, Group 1 only)
    2. Pancreatic carcinoma (Part 2, Group 2 only)
    3. Malignant mesothelioma with epithelioid histology, pleural or primary peritoneal (Part 2, Group 3 only)
  3. For Part 2 only - Measurable disease according to RECIST v1.1 for patients with ovarian cancer and pancreatic carcinoma, and mRECIST v1.1 for patients with mesothelioma
  4. 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 4 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks.
  5. ECOG performance status of 0 or 1
  6. Adequate bone marrow function,
  7. Adequate renal function,
  8. Adequate liver function,
  9. Serum albumin ≥30 mg/mL

Key Exclusion Criteria:

  1. Previously treated or current brain metastases
  2. Evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy; or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis
  3. Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening
  4. History of or known or suspected autoimmune disease
  5. History of clinically significant cardiovascular disease
  6. Clinically active or chronic liver disease
  7. Second primary malignancy that has not been in remission for greater than 3 years.
  8. 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, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute         
Contact    1-844-482-4812      
Sponsors and Collaborators
Harpoon Therapeutics

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Responsible Party: Harpoon Therapeutics
ClinicalTrials.gov Identifier: NCT03872206     History of Changes
Other Study ID Numbers: HPN536-2001
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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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