Combining SHR-A1811 with chemotherapy for recurrent ovarian cancer

An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

This study is testing a new treatment combining SHR-A1811 with chemotherapy to see if it helps people with recurrent ovarian cancer feel better and respond well to the therapy.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06840002 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety, tolerance, pharmacokinetics, and immunogenicity of SHR-A1811 when combined with carboplatin and bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian cancer. The study will determine the recommended phase 2 dose (RP2D) of this combination therapy and preliminarily assess its effectiveness. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are women with platinum-sensitive recurrent epithelial ovarian cancer who have measurable lesions and meet specific health criteria.

Not a fit: Patients with untreated or active central nervous system metastasis or significant symptomatic effusions 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 ovarian cancer.

How similar studies have performed: While this approach is being evaluated in this specific context, similar combinations of chemotherapy and targeted therapies have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
3. At least one measurable lesion conforming to RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 12 weeks.
6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Exclusion Criteria:

1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
4. With hypertension and cannot be well controlled by antihypertensive drug treatment.
5. Accompanied by poorly controlled or serious cardiovascular diseases.
6. Subjects with serious infection within 1 month before the first medication.
7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Shuni Wang

Conditions: Ovarian Cancer