New treatment for ovarian cancer that doesn't respond to platinum-based therapies

A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

This study is testing a new treatment called SHR-A1921 to see if it works better than standard chemotherapy for people with ovarian cancer that doesn't respond to platinum-based therapies.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06394492 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the efficacy and safety of SHR-A1921 compared to standard chemotherapy options in patients with platinum-resistant recurrent epithelial ovarian cancer. The study is randomized and open-label, meaning participants are assigned to different treatment groups without blinding. Eligible patients must have a confirmed diagnosis of ovarian cancer and measurable disease, and they will receive either SHR-A1921 or the investigator's choice of chemotherapy. The trial aims to determine if SHR-A1921 can provide better outcomes than existing treatments.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with platinum-resistant recurrent epithelial ovarian cancer.

Not a fit: Patients with uncontrolled effusions, other malignancies, or significant heart issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with a challenging form of ovarian cancer.

How similar studies have performed: While there have been studies on similar treatments, the specific approach of SHR-A1921 is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumour tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy ≥ 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.

Exclusion Criteria:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Current or History of ILD.
4. Clinical symptoms or diseases of the heart that are not well controlled.
5. Arterial/venous thrombosis events occurred before the first dose.
6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.
7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
8. Patients with intestinal obstruction or parenteral nutrition before the first dose.
9. Serious infection before the first dose.
10. Active hepatitis B or active hepatitis C.
11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
15. Other inappropriate situation considered by the investigator.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Shuni Wang

Conditions Ovarian Cancer