About this trial
This study is a randomized, open-label, controlled phase II clinical trial.
It is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi).
Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).
Eligibility criteria
Qualifiers
Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.
Aged 18 to 75 years.
Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse).
Disqualifiers
Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.
Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.
Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.
Untreated or active central nervous system (CNS) metastases.
Trial design
Treatments tested in this trial
- Trastuzumab Rezetecan (SHR-A1811)
- Carboplatin
- Bevacizumab
- Bevacizumab
- Carboplatin + Paclitaxel
- Carboplatin + pegylated liposomal doxorubicin
- Carboplatin + Gemcitabine