RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression

Inclusion Criteria:

• Female subjects aged from 18 to 75 years old;

• Pathology confirmed the diagnosis of primary epithelial ovarian/fallopiantube/peritoneal carcinoma;

• Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenancetherapy after complete clinical or pathological response;Previously not receivingtargeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trialentry;

• Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);

• Estimated life expectancy of more than 3 months;

• Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able toprovide samples of the primary or metastatic site of the tumor for HER2detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）

• Adequate haematological, hepatic and renal functions defined by the protocol;

• Negative blood pregnancy test at Screening for women of childbearing potential;Highly effective contraception for female subjects if the risk of conception exists;

Exclusion Criteria:

• The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer ormetastatic ovarian cancer;

• The patient has ≥ grade 2 peripheral neuropathy;

• Patients with active bleeding or pathological conditions with high risk of bleeding,such as known hemorrhagic diseases, coagulation disorders, or tumors involving largeblood vessels;

• Suffering from central nervous system metastasis and/or cancerous meningitis. Exceptfor stable brain metastases; 5.The toxicity caused by previous anti-tumor treatmentshas not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hairloss);

• Patients who require parenteral hydration or nutrition and have evidence of partialintestinal obstruction or perforation;

• Except for patients with primary endometrial cancer or a history of primaryendometrial cancer, unless all of the following conditions are met: stage notgreater than I-B stage; No more than superficial muscle infiltration, no vascular orlymphatic infiltration; No poorly differentiated subtypes, including papillaryfluid, clear cells, or other FIGO grade 3 lesions;

• For patients undergoing cell reduction surgery before treatment, if combined withbevacizumab, they must wait for at least 28 days before starting the treatment withbevacizumab;

• Have undergone major surgery within 4 weeks prior to the start of studyadministration and have not fully recovered;

• A large amount of pleural or ascitic fluid accompanied by clinical symptoms orrequiring symptomatic treatment;

• Within 30 days of initial medication or expected to receive attenuated live vaccinesduring the study period;

• Serious arterial/venous thrombotic events or cardiovascular and cerebrovascularaccidents that occurred within one year prior to drug administration were studied;

• There are systemic diseases that have not been controlled stably according to thejudgment of the researcher, including diabetes, liver cirrhosis (Child Pugh Class Bor C), interstitial pneumonia, obstructive pulmonary disease, etc;

• Clinically significant cardiovascular disease patients(According to the specificrequirements of the plan);

• Individuals with active autoimmune diseases or immunodeficiency, or a history of theaforementioned conditions, including but not limited to autoimmune hepatitis,interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease,pituitary inflammation, vasculitis, nephritis, etc., shall not be included. Thefollowing exceptions apply: Patients with a history of autoimmune hypothyroidism whohave received thyroid hormone replacement therapy may be included in the study.Patients with type 1 diabetes whose blood sugar can be controlled after treatmentwith insulin administration scheme can participate in this study;

• Subjects with a history of other malignant tumors within five years (excludingcomplete treatment for in situ cervical cancer, basal cell carcinoma, or squamouscell carcinoma skin cancer);

• Patients with congenital or acquired immune deficiency, such as humanimmunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 2000 IU / ml),hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit ofthe analytical method), or co infection of hepatitis B and hepatitis C;

• Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviraldrugs) occurred within 4 weeks before the first administration, or fever (>38.5%) ofunknown reason occurred during the screening period/before the first administration；

• Currently participating in intervention clinical research treatment, or receivingother investigational drugs or research instruments within 4 weeks prior to thefirst administration; Not fully recovered from toxicity and/or complications causedby any intervention measures prior to initial administration (i.e. ≤ level 1 orreaching baseline, excluding fatigue or hair loss);

• Has a clear history of allergies and may have potential allergies or intolerance tothe investigational drug and its similar biological agents;

• Individuals with a history of abuse of psychotropic substances who are unable toquit or have mental disorders;