Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Conditions
Interventions
Cohort 1:Administer Becotatug Vedotin at a dose of 2.3 mg/kg intravenously on day 1 of each 3-week treatment cycle.
Cohort 2:Becotatug Vedotin plus Bevacizumab
Becotatug Vedotin: The dosing cycle is every 3 weeks, with 2.0 or 1.5 mg/kg administered on the first day of each cycle via intravenous infusion.
Bevacizuma
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in this study, signed the informed consent form, and had good compliance. 2. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by histology. 3. EGFR protein expression positive confirmed by IHC. 4. Platinum-resistant relapsed patients, defined as disease progression during the most recent platinum-based chemotherapy or within 6 months after the last platinum-based chemotherapy. After confirming platinum resistance, subjects are allowed to receive subsequent non-platinum treatment regimens. 5. Age 18-75 years. 6. At least one measurable lesion according to RECIST v1.1 criteria. 7. Eastern Cooperative Oncology Group (ECOG) performance score 0-1. 8. Expected survival of more than 3 months. 9. Cohort 2: Time since last bevacizumab use >= 6 months. 10. Normal major organ function, as defined by the following criteria: absolute neutrophil count >= 1.5×10^9, platelets >= 100×10^9, hemoglobin >= 90g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5×upper limit of normal (UNL), total bilirubin < 1.5×UNL, serum creatinine < 1.5×UNL. 11. Subjects with potential fertility must use at least one medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and for 180 days after the end of the study treatment; and a negative serum/urine HCG test must be obtained before the first dose; and must not be in the lactation period.
Exclusion criteria
Exclusion criteria: 1. Known allergies to any medication used in the study; 2. Persistent toxic effects (excluding alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant laboratory abnormalities exceeding grade 1 (CTCAE v5.0) resulting from prior antineoplastic therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy); 3. Severe or uncontrolled cardiac disease or clinical symptoms requiring treatment, including: • Congestive heart failure classified as NYHA Class 3 or 4 or left ventricular ejection fraction (LVEF) = 450 ms in males or >= 470 ms in females) (QTc interval calculated using the Fridericia formula); 4. Arteriovenous thrombotic events occurring within 6 months prior to the first dose of medication, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (excluding cases where venous thrombosis was caused by prior chemotherapy-related venous catheterization and deemed resolved by the investigator), pulmonary embolism, or recent peripheral arterial thrombosis formation; 5. Individuals with active ulcers, intestinal perforation, or intestinal obstruction 6. Those with active bleeding or a tendency to bleed; 7. Suffering from hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); 8. Received systemic chemotherapy within 3 weeks before the first administration of the study drug; received small molecule targeted therapy within 2 weeks before the first administration or within 5 half-lives (whichever is longer); underwent major surgery within 28 days before the first administration (major surgery in this study is defined as surgery requiring at least 3 weeks of postoperative recovery time before participating in the study); 9. Urinalysis indicates proteinuria >= ++ and confirms a 24-hour urinary protein excretion >1.0g; 10. Uncontrollable pleural effusion, pericardial effusion, or ascites despite appropriate intervention; 11. History of other malignant tumors within the past five years, excluding cured cervical in situ cancer or basal cell carcinoma of the skin; 12. HIV positive; 13. Symptomatic brain metastasis patients (confirmed or suspected); 14. The researchers believe that the subjects have any clinical or laboratory abnormalities or other reasons that make them ineligible to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS;Disease control rate,DCR;Duration of Response,DoR;overall survival, OS;According to the results of the FACT-O quality of life survey questionnaire; | — |
Countries
China
Contacts
Public ContactLan Chunyan
Sun Yat-sen University Cancer Center
Outcome results
None listed