Treatment for recurrent ovarian cancer using Disitamab Vedotin and Anlotinib.

Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for the Treatment of HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer.

This study is testing a new combination of two drugs, Disitamab Vedotin and Anlotinib, to see if it can help people with recurrent ovarian cancer that is resistant to standard treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Second Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: anlotinib, Vidiximab, vediximab, chemotherapy, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06660511 on ClinicalTrials.gov

What this trial studies

This study explores the safety and efficacy of combining Disitamab Vedotin with Anlotinib Hydrochloride for patients suffering from HER-2-expressing recurrent platinum-resistant ovarian cancer. Given the poor prognosis and limited treatment options for this patient population, the study aims to evaluate a new therapeutic approach that may improve outcomes. Participants will be closely monitored for response rates and side effects, with a focus on enhancing quality of life. The study is designed for patients who have shown HER2 expression and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older with HER2-expressing recurrent ovarian cancer who have not responded to platinum-based therapies.

Not a fit: Patients with platinum-sensitive recurrent ovarian cancer or those who do not express HER2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with recurrent platinum-resistant ovarian cancer.

How similar studies have performed: While there is limited data on this specific combination, other studies have explored similar approaches with varying degrees of success, indicating potential but also uncertainty.

Eligibility criteria

Inclusion Criteria:

1. The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
2. Age ≥ 18 years old when signing the informed consent form;
3. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by organizational or cellular pathology;
4. The subjects can provide tumor primary or metastatic site specimens for HER2 detection (paraffin blocks, paraffin embedded sections, or fresh tissue sections are all acceptable), and the immunohistochemical (IHC) test results show HER2 expression: IHC 1+, 2+, or 3+; 4) ECOG PS: 0-1 point;
5. Expected survival period\>12 weeks;
6. Adequate heart, bone marrow, liver, and kidney function (based on normal values at the research center);
7. At least one measurable lesion defined in RECIST version 1.1;
8. Women of childbearing age must meet one of the following conditions:

   * Surgical sterilization has been performed; ② Menopausal individuals who have stopped menstruating for at least one year; ③ Having the ability to conceive requires meeting the following conditions:; The serum pregnancy test result before the first medication is negative and must be a non lactating subject; During the entire study period, it was agreed to use a recognized method of contraception (such as oral contraception, injection contraception, or implanted barrier contraception, spermicides and condoms, or intrauterine devices), and the contraceptive method remained unchanged throughout the study period.

Exclusion criteria：

1. Previously received ADC drugs for HER2 treatment or similar TKI small molecule anti angiogenic drugs such as anlotinib hydrochloride;
2. Subjects with primary platinum refractory diseases;
3. Patients with untreated central nervous system metastases (including new and progressive brain metastases), a history of leptomeningeal metastases or malignant meningitis;
4. Individuals with symptoms and signs of intestinal obstruction and requiring parenteral nutrition and fluid replacement;
5. Patients with any signs of bleeding or history of bleeding, regardless of the severity: patients who have experienced any bleeding or bleeding events ≥ CTCAE grade 3 within the 4 weeks prior to the first dose; Or there may be unhealed wounds, fractures, active ulcers in the stomach and duodenum, ulcerative colitis and other digestive diseases.
6. Within 6 months, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; (Individuals with a tendency towards thrombosis or undergoing anticoagulant therapy are allowed to use prophylactic anticoagulant therapy)
7. Serious cardiovascular and cerebrovascular diseases or discomfort, including but not limited to the following diseases:

   * Diagnosed history of heart failure or systolic dysfunction (LVEF\<50%)
   * High risk uncontrolled arrhythmia
   * Angina pectoris, acute myocardial infarction
   * Clinically significant heart valve disease
   * Poor control of hypertension (systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>100 mmHg)
8. The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) grade 0-1 (excluding 2nd degree hair loss);
9. Individuals who have undergone major surgery within 4 weeks prior to their first medication and have not fully recovered, or are expected to undergo surgical treatment;
10. Patients with other malignant tumors within 3 years prior to the first use of medication, excluding papillary thyroid carcinoma, basal cell or squamous cell carcinoma that have been adequately treated and have no evidence of disease recurrence, as well as other in situ cancers that have been adequately treated and have no evidence of disease recurrence (including but not limited to cervical primary cancer, ductal carcinoma in situ of the breast, etc.);
11. Imaging (CT or MRI) shows that the tumor has invaded important blood vessels or is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies, as determined by the researcher;
12. Patients with clinical symptoms of pleural effusion, pericardial effusion, or ascites who require repeated puncture and drainage, or those who have received treatment within the previous month for the purpose of drainage;
13. Individuals with a known history of allergies to the components of this medication regimen;
14. Pregnant and lactating female patients;
15. Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study

Where this trial is running

Changsha, Hunan

• Xiangya Second Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: jingjing Wang

Conditions Ovarian Cancer Recurrent