A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors

Has received chemotherapy within 21 days prior to the first administration of GH2616 Tablet or has received radiation therapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28 days prior to the first administration of GH2616 Tablet, or other anti-tumor drugs or treatments within the following interval before the first administration of GH2616 Tablet: Nitrosoureas or mitomycin C within 6 weeks prior to the first administration of the investigational drug. Oral fluoropyrimidines, small molecule targeted therapies, and Chinese herbal medicines with indications for anti-tumor within 14 days prior to the first administration of the investigational drug. Local palliative radiation therapy within 14 days prior to the first administration of the investigational drug.

Has received other investigational drugs or treatments not yet approved for marketing within 28 days prior to the first administration.

Acute toxic effects of prior anti-tumor therapy have not recovered to clinically significant NCI-CTCAE V5.0 grade ≤ 1 toxicity or baseline specified in the inclusion criteria within 28 days prior to the first administration of GH2616 Tablet (excluding toxicities such as alopecia and fatigue that the Investigator deems to have no safety risk).

At rest, the average Corrected QT interval (QTc, Fridericia's correction formula used) obtained by 12-lead Electrocardiograph (ECG) examination is > 450 ms for males or 470 ms for females (confirmed by repeated examinations). A variety of clinically significant arrhythmia, conduction, and resting ECG abnormalities, such as complete left bundle branch block, degree III, degree II, PR interval >250 ms. Various factors that may increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome in a direct family member or sudden unexplained death before age 40, and use of any medications known to prolong QT intervals.