A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors

Inclusion Criteria

• Written informed consent obtained prior to any study-related procedure being performed;
• Age 18 years or older;
• Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
• Patients with life expectancy ≥3 months;
• Patients must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group performance score 0 or 1;
• Patients who have sufficient baseline organ function.

Exclusion Criteria

• Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
• Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
• Patients who have impaired cardiac function or clinically significant cardiac diseases;
• Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
• Use of an investigational drug during the past 30 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
• No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is to be permitted while the patient is receiving study medication.