Clinical Trials /

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

NCT03872206

Description:

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.

Related Conditions:
  • Epithelioid Mesothelioma
  • Fallopian Tube Carcinoma
  • Malignant Pleural Mesothelioma
  • Ovarian Carcinoma
  • Pancreatic Adenocarcinoma
  • Peritoneal Malignant Mesothelioma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression
  • 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

Clinical Trial IDs

  • ORG STUDY ID: HPN536-2001
  • NCT ID: NCT03872206

Conditions

  • Advanced Cancers Associated With Mesothelin Expression

Interventions

DrugSynonymsArms
HPN536HPN536-2001

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
HPN536-2001ExperimentalPart 1 (Dose Escalation): will include eligible patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or pancreatic adenocarcinoma. 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): 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.
  • HPN536

Eligibility 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 or primary peritoneal
                  (Part 2, Group 3 only) that is progressive disease following frontline
                  platinum-based chemotherapy

          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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assess initial safety and determination of recommended Phase 2 dose: Dose limiting toxicity
Time Frame:1 year
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Harpoon Therapeutics

Last Updated

December 13, 2019