Ovarian Cancer Clinical Trials

• Fully understand the contents, process and possible adverse reactions of the study before the study, sign the informed consent form, voluntarily participate in the study, and be able to complete the study according to the requirements of the study protocol;

• Aged ≥ 18 years at the time of signing ICF;

• Participants with histologically or cytologically confirmed advanced or metastatic solid tumors who have failed at least one line of standard systemic therapy in the advanced or metastatic setting (participants who received neoadjuvant or adjuvant therapy and experienced progressive disease or relapse within 6 months after completion of such therapy will be considered to have failed one line of standard therapy), or for whom no effective standard therapy is available, or who are intolerant of or refuse standard systemic therapy;

• At least 1 measurable lesion per RECIST v1.1 within 4 weeks prior to the first dose; for participants who have received prior radiotherapy, a previously irradiated lesion may be considered a target lesion if it is measurable per RECIST v1.1 and there is objective evidence of significant progression following radiotherapy; brain metastatic lesions may not serve as target lesions;

• ECOG performance status of 0 or 1 within 7 days prior to the first dose;

• Expected survival of more than 3 months;

• At least 28 days must have elapsed between the first dose of investigational drug and any prior major surgical procedure, medical device treatment, local radiotherapy (except palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biologic therapy; at least 14 days must have elapsed since prior small-molecule targeted therapy or hormonal therapy; at least 7 days must have elapsed since prior traditional Chinese medicine with antitumor indications or minor surgery; and any treatment-related AEs must have recovered to CTCAE v6.0 Grade ≤ 1 (except alopecia);

• The participant agrees to provide archival tumor tissue specimen sufficient to meet testing requirements (from the most recent surgery or biopsy, preferably within 3 years) or agrees to undergo a fresh biopsy for tumor tissue collection (unless the investigator determines that the procedure would pose an unacceptable risk to the participant's safety), for assessment of tumor sialylation and protein expression including B7-H3; Note: Participants are required to provide a formalin-fixed, paraffin-embedded (FFPE) tumor sample (paraffin block or unstained sections, meeting quality control standards for testing) collected from a non-irradiated site at the time of or after the diagnosis of malignancy, from the most recent surgery or biopsy, along with the corresponding pathology report for the above specimen.

• Adequate organ function confirmed by laboratory assessments performed within 7 days prior to the first dose of study drug (without receipt of transfusions, granulocyte colony-stimulating factors, or thrombopoietic agents within 14 days prior to the first dose):

• Hematologic System Absolute neutrophil count (ANC) ≥ 1.0 × 109/L Platelet count (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Liver Function Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), unless a known genetic cause of elevated bilirubin is present (e.g., Gilbert's syndrome) Alanine aminotransferase (ALT) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Aspartate aminotransferase (AST) ≤ ULN; ≤ 2.5 × ULN for participants with hepatic metastases or hepatocellular carcinoma Renal Function Creatinine (Cr) ≤ 1.5 × ULN; if \> 1.5 × ULN, creatinine clearance must be ≥ 40 mL/min (calculated using the Cockcroft-Gault formula) Coagulation Function (unless the participant is receiving anticoagulant therapy) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Prothrombin time (PT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN

⁃ Male and female participants of childbearing potential must agree to use at least 1 highly effective method of contraception during the study and for at least 6 months after the last dose of investigational drug; female participants of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

⁃ The tumor type for participants with advanced solid tumors may be any of the following:

∙ Platinum-resistant ovarian cancer

‣ Other advanced/metastatic solid tumors with B7-H3 expression confirmed by IHC.

⁃ Participants with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer must also meet all of the following criteria:

∙ Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer, with no evidence of non-epithelial carcinoma, borderline tumor, mucinous carcinoma (or seromucinous carcinoma with a predominant mucinous component), malignant Brenner tumor, or undifferentiated carcinoma.

‣ Participants must have received at least 2 prior lines of therapy for metastatic ovarian cancer, including at least 1 platinum-based regimen, or must be intolerant to such standard treatments.

‣ Must be platinum-resistant, defined as progressive disease confirmed by CA-125, clinical, or imaging assessment within 6 months after the last platinum-containing chemotherapy regimen.