Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma
Trial ID or NCT#
This study will be conducted in adult participants diagnosed with NSCLC who have been previously treated for a minimum of 12 weeks with any PD-1 or PD-L1 checkpoint inhibitor. This is a phase 1b/2, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate disease response with grapiprant based on investigator assessments. Pharmacokinetics, pharmacodynamics and response biomarkers will also be assessed.
Open Label, Single Arm, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma
- - Male and female adult patients at least 18 years of age on day of signing informed consent - Histologically confirmed non-small cell lung cancer (NSCLC) adenocarcinoma - Advanced (stage IIIb) disease that is not amenable to curative intent treatment with concurrent chemoradiation and metastatic (stage IV) patients - Progressed clinically and/or radiographically per RECIST v1.1 after receiving a PD-1 or PD-L1 antagonist for a minimum of 12 weeks - Measurable disease per RECIST v1.1 - Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy for multiple core biopsies and participant is willing to provide tissue from newly obtain biopsies on study in a subgroup of patients - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Adequate organ function - Highly effective birth control - Able to swallow and absorb oral tablets Key
- - Current use of NSAIDs, COX-2 inhibitors - Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS gene alteration - No history of smoking (≤100 cigarettes lifetime) - History of severe hypersensitivity reactions to a PD-1/L1 antibody - Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment or 5 half-lives, whichever is shorter - Received prior radiotherapy within 2 weeks of start of study treatment - Has received a live vaccine within 30 days prior to the first dose of study treatment - Taking strong CYP3A4 or P-glycoprotein inhibitors or inducers - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment - Known additional malignancy that is progressing or has required active treatment within the past 3 years (with some permitted exceptions) - Known active CNS metastases and/or carcinomatous meningitis - Active autoimmune disease that has required systemic treatment in past 2 years - History of pneumonitis that required steroids or has current pneumonitis - Has an active infection requiring systemic therapy - Recent or current GI ulcer, colitis or non-immune colitis - Known history of human immunodeficiency virus (HIV) infection, or known active Hepatitis B, or Hepatitis C virus infection - Has had an allogeneic tissue/solid organ transplant - Clinically significant (i.e.active) cardiovascular disease
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