Status:
COMPLETED
Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression
Lead Sponsor:
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Advanced Cancers Associated With Mesothelin Expression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.(Phase 2 portion of the study...
Eligibility Criteria
Inclusion
- One of the following progressive advanced or metastatic cancers:
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum refractory or platinum resistant
- Pancreatic adenocarcinoma that is locally advanced, and now with progressive disease on or after front-line treatment
- Malignant mesothelioma with epithelioid histology, pleural or peritoneal
- 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
- Available archival tissue sample, or fresh biopsy tissue sample must be obtained prior to enrollment. For Part 2 only- a fresh biopsy tissue sample is required.
- Adequate bone marrow function, including:
- Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
- Platelets ≥100,000/mm3 or ≥100 x 109/L
- Hemoglobin (Hgb) ≥9 g/dL
- Adequate renal function, including estimated creatinine clearance ≥30 mL/min
- Adequate liver function, including:
- 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
- Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
- Serum albumin ≥30 mg/mL
- Key Exclusion Criteria:
- Brain metastases unless previously treated. 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
- 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 based on computed tomography (CT), magnetic resonance imaging (MRI), or echocardiogram (ECHO); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis.
- Previous Grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody.
- For patients with tumor types other than pleural mesothelioma: Ascites requiring \>1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to Cycle 1 Day 1.
Exclusion
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03872206
Start Date
April 16 2019
End Date
January 4 2023
Last Update
June 7 2024
Active Locations (16)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
University of Southern California
Los Angeles, California, United States, 90007
3
University of California Los Angeles
Los Angeles, California, United States, 90095-7170
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224