APL-101 Study for NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advance Solid Tumors

For people ages 18 years and up

Major Inclusion Criteria:

• Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
• For Phase 1, histologically and / or cytological confirmed locally advanced, recurrent or relapsed or metastatic incurable solid malignancy
• For Phase 2, three cohorts will be enrolled: Cohort A: EXON 14 NSCLC (c-Met naïve),

Cohort B: EXON 14 NSCLC (c-Met experienced; progressed on prior c-Met inhibitor),

Cohort C: basket of tumor types with c-Met dysregulation (amplification or mutation or fusions).

• Measurable disease according to RECIST v1.1. 7.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• No planned major surgery within 4 weeks of first dose of APL-101

Major Exclusion Criteria:

• Hypersensitivity to CBT-101, excipients of the drug product, or other components of the study treatment regimen.
• Known mutation of EGFR, ALK or ROS1 or have received a kinase inhibitor for these mutations
• History of, or at risk for, cardiac disease (e.g., long QTc syndrome [> 450 msec] or concurrent treatment with any medication that prolongs QT interval).
• Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids.
• Unable to swallow orally administered medication whole.
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
• Women who are breastfeeding.