SHS_492302 GOLP CHAL 15214

A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan High Solid Tumors

This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab for subjects with relapsed/refractory advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have failed at least 1 platinum-based chemotherapy regimen and subjects with relapsed/refractory locally advanced or metastatic gastric adenocarcinoma after failing at least 1 chemotherapy regimen.

Inclusion Criteria:

Histologically confirmed and documented, previously treated stage IIIB or IV Non Small Cell Lung Cancer (NSCLC) having failed at least 1 previous platinum containing chemotherapy regimen or recurrent locally advanced or metastatic gastric adenocarcinoma having failed at least 1 previous chemotherapy regimen. Subjects with NSCLC who are known to be epidermal growth factor receptor (EGFR)-mutation positive must have received an EGFR inhibitor and subjects known to be anaplastic lymphoma kinase (ALK)-mutation positive must have received an ALK inhibitor.
Prior to enrollment, confirmation of the following must be obtained: Dose escalation - For subjects in the dose escalation portion of the study, it is preferred that there is available archived tumor tissue in a formalin-fixed paraffin-embedded (FFPE) block or 5-10 unstained core biopsy slides that meet specific tissue sample requirements, however it is not mandatory for enrollment in this portion of the study. Dose expansion - For subjects in the dose expansion portion of the study, it is mandatory that available archived tumor tissue in FFPE block or minimum of 5-10 unstained core biopsy slides that meet specific tissue sample requirements are available.
One or more tumors measurable on CT scan/MRI scan per RECIST v 1.1. Previously irradiated tumors may be eligible if they have clearly progressed in size.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy ≥3 months.

Exclusion Criteria:

Previous treatment with pembrolizumab, nivolumab, or other programmed cell death-1 antibody (anti- PD-1) or PD-1 ligand 1 antibody (anti-PD-L1) agents.
New York Heart Association Class III or IV (Appendix D) cardiac disease or myocardial infarction within the past 12 months before screening, or preexisting atrial fibrillation.
Prior history of cerebrovascular accident or transient ischemic attack.
Patients with known interstitial fibrosis or interstitial lung disease.
Previous history of pulmonary embolism or pulmonary embolism found on screening exam.
Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents.
History of another primary cancer within the last 3 years that required treatment, with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in situ.
Phase Ib
NCT02563548
Cancer
Gastrointestinal
Philip Gold, M.D.
Halozyme, Inc
Erik Bailey
  • Swedish Medical Center