A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment

Exclusion Criteria19

• Any previous treatment with a PARG inhibitor.
• Subjects known to be allergic to the study drug or its active ingredients or excipients;
• Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;
• Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;
• Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);
• Subjects who have an allogeneic tissue/ solid organ transplantation;
• Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;
• Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure.
• Central nervous system metastasis or disease;
• Subjects who have impaired heart functions or clinically serious heart disease；
• Have severe systemic active infection;
• Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;
• Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;
• Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU/mL or ≥ 103 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);
• Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;
• Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;
• Active autoimmune and inflammatory diseases；
• Women who are pregnant or breastfeeding；
• Subjects who are considered unsuitable for the study judged by the investigator.