A Phase 3 interventional study of trastuzumab and bevacizumab in Ovarian Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 3 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment
This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
Exclusion Criteria:
7. Individuals with poorly controlled or severe cardiovascular disease. 8. Individuals who have experienced arterial/venous thrombotic events within 6 months prior to randomization.
9. Individuals who have experienced NCI-CTCAE v6.0 grade ≥2 bleeding events within 1 month prior to randomization.
10. Individuals with known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendency.
11. Individuals who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess in the near future.
12. Individuals with gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 3 months prior to randomization; individuals who have previously undergone intestinal stent implantation and whose intestinal stent has not been removed by the screening period.
13. Participants who have experienced severe infection within 1 month prior to randomization.
14. Participants who have tested positive for human immunodeficiency virus (HIV); participants with known active hepatitis.
15. Participants who have undergone major surgery within 4 weeks prior to randomization or whose surgical side effects have not recovered or stabilized prior to randomization. 16. Patients who may receive other systemic anti-tumor therapies during treatment or are scheduled for further debulking surgery.
17. Patients whose toxicity from previous anti-tumor therapy has not recovered to grade ≤1 according to the NCI-CTCAE v6.0 classification.
18. Patients with known hypersensitivity to any component of the SHR-A1811 product or other monoclonal antibody drugs.
19. Patients who, in the investigator's judgment, have other factors that may affect the trial results or force the trial to be terminated midway, such as alcoholism, drug abuse, substance abuse, criminal detention, etc., as well as other serious illnesses (including mental illness) requiring concomitant treatment, serious abnormal laboratory test results, or any other circumstances that may increase the risk of participation in the trial, interfere with the trial results, or make them unsuitable for participation in the trial.
Drug: trastuzumab · Drug: bevacizumab
Drug: bevacizumab
trastuzumab
bevacizumab
Dose limited toxicity (DLT)
Time frame: up to 21 days
Progression Free Survival (PFS)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
AEs+SAEs
Time frame: from the first drug administration to within 40 days for the last treatment dose
Ctrough
Time frame: from the first drug administration to within 40 days for the last treatment dose
ADA
Time frame: from the first drug administration to within 40 days for the last treatment dose
Overall survival (OS)
Time frame: Approximately 3 years after last subject enrolled
Second progression-free survival (PFS2)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Objective Response Rate (ORR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Disease Control Rate (DCR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Duration of Response (DoR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to disease progression (TTP)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Cancer antigen-125 response rate (CA-125 RR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to the start of subsequent treatment (TFST)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.