Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors

Inclusion Criteria

• •Measureable disease according to RECIST Version 1.1
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Minimum age of 18 years
• •Adequate hematological, hepatic and renal function
• •Written consent on an Institutional Review Board-approved informed consent form prior to any study-specific evaluation
• •Histologically or cytologically confirmed diagnosis of one of the following:
• •1. Metastatic or unresectable locally advanced NSCLC with documented evidence that the tumor harbors one of the two common EGFR mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (exon 19 deletion, L858R), either alone or in combination with other EGFR mutations, determined by PCR-based testing of the tumor tissue or plasma sample, and without prior exposure to an EGFR-TKI therapy; OR
• •2. Metastatic or unresectable locally advanced NSCLC:
• •1. with documented evidence that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q); and
• •2. with evidence of radiological disease progression while on a previous continuous treatment with a first-generation EGFR TKI. In addition, other lines of therapy may have been given. All patients must have evidence of radiological disease progression on or following the last treatment administered; and
• •3. with documented evidence of EGFR T790M mutation determined by PCR-based testing of the tumor tissue or plasma sample following disease progression on most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy).