Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure

Exclusion Criteria

• •Prior or ongoing therapies as follows:
• •1. Prior or current use of treatments targeting B7-H3
• •2. Prior or current use of treatments with topoisomerase I inhibitors, including antibody-drug conjugates that are effectively loaded with topoisomerase I inhibitors
• •3. Prior or current use of systemic anti-tumor therapy with gemcitabine in combination with docetaxel;
• •4. Use of cytotoxic chemotherapy drugs, experimental drugs, traditional Chinese medicines for anti-tumor indicationsor other anti-tumor drugs within 14 days prior to randomization; or requiring continued use of such drug therapies during the study;
• •5. Use of macromolecular anti-tumor drug therapy within 28 days prior to randomization;
• •Presence of residual grade ≥ 2 toxicities by Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous treatments.
• •History of other primary solid tumors.
• •Inadequate bone marrow reserve or liver and kidney organ function, which meets any of the following laboratory limits:
• •Serious, uncontrolled or active cardiovascular diseases.
• •Severe or poorly controlled diabetes, including: ① Diabetic ketoacidosis or hyperglycemia and hyperosmolarity within 6 months prior to randomization; or ② other severe or poorly controlled diabetes conditions as determined by the investigator.
• •Severe or poorly controlled hypertension, including: history of prior hypertensive crisis or hypertensive encephalopathy; adjustment of antihypertensive drug therapy within two weeks prior to randomization due to poor blood pressure control; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg during the screening period.
• •Have clinically significant hemorrhage symptoms or significant hemorrhagic diathesis within 1 month before randomization.
• •Serious arteriovenous thrombotic events within 3 months before randomization, such as deep vein thrombosis, pulmonary embolism, etc. .
• •Severe infection within four weeks prior to randomization, including but not limited to complications of infection, bacteremia, or severe pneumonia requiring intravenous antibiotic therapy for ≥ 2 weeks; or uncontrollable active infection during the screening period. Study participants who are receiving or have received prophylactic antibiotics may be enrolled.
• •Patients who have received continuous glucocorticoid therapy for more than 30 days within 30 days before randomization, or who require long-term (≥ 30 days) use of glucocorticoids, or patients with other acquired/congenital immunodeficiency diseases or with a history of transplantation (except for corneal transplantation). Systemic corticosteroids (≤ 10 mg/d prednisone or equivalent) at a physiological replacement dose are permitted.
• •Known presence of infectious diseases, such as hepatitis B , hepatitis C, tuberculosis , syphilis, or HIV infection , etc. Active infectious diseases will not be screened for proactively.
• •Existing hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis.
• •Known interstitial pneumonia or immune pneumonitis, other moderate-to-severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and severely affect respiratory function.
• •A history of prior serious neurological or psychiatric disorders, including epilepsy, dementia, severe depression, or other conditions that can interfere with the assessment.
• •Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study.
• •Vaccination or occurrence of any degree of allergic or hypersensitivity reaction within four weeks prior to the first dosing.
• •Subjects who have previously experienced severe allergies or serious infusion reactions, or who are allergic to recombinant humanized or murine protein substances.
• •‬Allergies to any component of the study drug HS-20093 , gemcitabine and its excipients, and docetaxel and its excipients.
• •Patients who may have poor compliance with the study procedures and requirements as judged by the investigator.
• •Patients with any condition that, in the Investigator's judgment, jeopardizes their safety or interferes with study assessments.