HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

Exclusion Criteria35

• Have received or is currently receiving the following treatment:
• B7-H4-targeted therapies.
• 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.
• 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.
• 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.
• Major surgery (such as craniotomy, thoracotomy or laparotomy, etc.) within 4 weeks prior to the first dose of study treatment.
• 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.
• 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.
• 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).
• Presence of pleural/abdominal effusion requiring clinical intervention.
• Known history of prior malignancy.
• Evidence of brain metastasis, unless meeting all of the following criteria:
• Asymptomatic; medically stable for at least four weeks prior to the first dose;
• No steroid treatment required for at least two weeks prior to the first dose;
• No stereotactic radiation therapy, whole brain radiotherapy, and/or neurosurgical resection within 4 weeks prior to the first dose;
• No history of intracranial or spinal hemorrhage;
• Have at least one target lesion other than CNS lesion according to RECIST v1.1;
• Inadequate bone marrow reserve or hepatic/renal functions.
• Cardiological examination abnormality.
• Severe, uncontrolled or active cardiovascular disorders.
• Serious or poorly controlled diabetes.
• Serious or poorly controlled hypertension.
• Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
• Serious arteriovenous thromboembolic events within 3 months prior to the first dose of study treatment.
• Serious infections within 4 weeks prior to the first dose.
• 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.
• Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
• Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
• 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.
• History of severe neurological or psychiatric disorder.
• Pregnant or breast-feeding women or women who intend to become pregnant during the study.
• Attenuated live vaccination within 4 weeks prior to the first dose.
• 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.
• Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
• Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.