A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
Eligibility criteria
Qualifiers
Fully understand this clinical trial and voluntarily sign the written informed consent form
Age ≥ 18 years old
Histologically or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer
Cohort A and B：subjects with platinum-sensitive disease who have received ≤2 prior lines of systemic chemotherapy and if have a BRCAm or HRD-positive status must have recieved PARP inhibitor maintenance therapy; Cohort C: subjects with platinum-resistant disease who have received ≤3 prior lines of systemic chemotherapy
Disqualifiers
Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy
History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll)
Subjects with active central nervous system (CNS) manifestations during the screening period, CNS metastases requiring corticosteroid therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis.
Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk)
Trial design
Treatments tested in this trial
- SYS6041, bevacizumab
- SYS6041, carboplatin, bevacizumab
- paclitaxel, carboplatin, bevacizumab
- SYS6041, enlonstobart, bevacizumab
Treatment groups
171 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov