A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

Key Inclusion Criteria:

* Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures
* Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology
* Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
* At least 1 measurable target lesion that meets the definition of RECIST v1.1
* ECOG Performance Status of 0 or 1
* Demonstrate adequate organ function
* Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption

Key Exclusion Criteria:

* History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled
* Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks
* Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months
* Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Pregnant or nursing
* Prior treatment with any SHP2 inhibitors
* Any condition that required systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration
* Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration