A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors

Exclusion criteria

• . Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up periods of interventional studies.
• . For participants with ovarian cancer, mixed tumors containing sarcomatous components or borderline ovarian tumors.
• . Prior receipt of any of the following treatments:
• . Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy, etc. For oral PARP inhibitors and traditional Chinese medicines indicated for antineoplastic therapy, the washout period is 2 weeks or 5 half-lives, whichever is longer.
• . Receipt of strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors (see Appendix 8) within 2 weeks prior to first dose or within 5 half-lives of the known drug, whichever is longer.
• . Receipt of live vaccine vaccination within 4 weeks prior to first study drug administration, or planned receipt of any live vaccine during the study.
• . Persistence of adverse reactions from prior antineoplastic therapy that have not resolved to Grade 0, Grade 1, or baseline status per NCI-CTCAE v5.0 criteria prior to first study drug administration. Participants with unresolved, stable chronic (\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.
• . Major surgery (craniotomy, thoracotomy, or laparotomy, and other surgical types considered "major" by the investigator, excluding needle biopsy) within 4 weeks prior to first study drug administration, or anticipated major surgery during the study, or presence of serious unhealed wounds, trauma, or ulcers, etc.