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 toinitiation of any study specific activities/procedures

• Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histologyor cytology

• Relapsed or refractory to, or intolerant of, or refuse approved or standard of careestablished 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 gastrointestinalabnormalities that significantly affect drug absorption

Key Exclusion Criteria:

• History of another concurrent malignancy within 3 years prior to study entry, unlessthe 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 theskin or carcinoma in the situ of the cervix may be enrolled

• Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects withasymptomatic treated CNS metastases are eligible provided they have been clinicallystable and not requiring steroids for at least 4 weeks

• Clinically significant cardiovascular disease, including stroke or myocardialinfarction within 6 months

• Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, exceptalopecia, 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 mgdaily of prednisone or equivalent) or other immunosuppressive medication ≤14 daysbefore the first study treatment administration

• Treatment with other investigational drugs/devices within 4 weeks prior to firststudy treatment administration