HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

Exclusion Criteria

• •1. Have received or is currently receiving the following treatment:
• •1. B7-H4-targeted therapies.
• •2. Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, biotherapy, etc.) within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
• •3. Have received macromolecular antitumor drugs (including immunotherapy, such as monoclonal antibodies and bispecific antibodies) within 28 days prior to the first dose of study drug.
• •4. Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
• •5. Major surgery (such as craniotomy, thoracotomy or laparotomy, etc.) within 4 weeks prior to the first dose of study treatment.
• •6. Use of strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP, or sensitive substrates of CYP3A4, CYP2D6, P-gp, or BCRP with narrow therapeutic window within 7 days prior to the first dose of study drug; or in need of continuing treatment with these drugs during the study.
• •7. Current use of drugs known to prolong the QT interval or potentially cause torsades de pointes; or need to continue these medications during the study.
• •2. Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) due to prior anti-tumor therapy (except alopecia and residual neurotoxicity).
• •3. Presence of pleural/abdominal effusion requiring clinical intervention.
• •4. Known history of prior malignancy.
• •5. Evidence of brain metastasis, unless meeting all of the following criteria:
• •1. Asymptomatic; medically stable for at least four weeks prior to the first dose;
• •2. No steroid treatment required for at least two weeks prior to the first dose;
• •3. No stereotactic radiation therapy, whole brain radiotherapy, and/or neurosurgical resection within 4 weeks prior to the first dose;
• •4. No history of intracranial or spinal hemorrhage;
• •5. Have at least one target lesion other than CNS lesion according to RECIST v1.1;
• •6. Inadequate bone marrow reserve or hepatic/renal functions.
• •7. Cardiological examination abnormality.
• •8. Severe, uncontrolled or active cardiovascular disorders.
• •9. Serious or poorly controlled diabetes.
• •10. Serious or poorly controlled hypertension.
• •11. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
• •12. Serious arteriovenous thromboembolic events within 3 months prior to the first dose of study treatment.
• •13. Serious infections within 4 weeks prior to the first dose.
• •14. Have received systemic glucocorticoid therapy for more than 30 days within 30 days prior to the first dose study treatment, or require chronic (≥ 30 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.
• •15. Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
• •16. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
• •17. Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
• •18. History of severe neurological or psychiatric disorder.
• •19. Pregnant or breast-feeding women or women who intend to become pregnant during the study.
• •20. Attenuated live vaccination within 4 weeks prior to the first dose.
• •21. Allergies or hypersensitivity reactions within 4 weeks prior to the first dose. History of severe allergies (e.g., anaphylactic shock), or severe infusion-related reactions. Allergy or hypersensitivity to any component of HS-20089.
• •22. Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
• •23. Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.