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This study is a randomized, open-label, controlled, multicenter phase â…¢ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6002 | Experimental | SYS6002 monotherapy |
|
| Chemotherapy | Active Comparator | Investigator's choice of one chemotherapy treatment (topotecan, gemcitabine, pemetrexed, or docetaxel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6002 | Drug | SYS6002,intravenous injection |
| |
| Investigator's Choice of Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive | Up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. | Up to 3.5 years |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
1. Has other histologies not mentioned as part of the inclusion criteria 2;
2. Active central nervous system metastases or leptomeningeal metastasis;
3. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk);
4. Any serious and/or uncontrolled concurrent illness that may interfere with patient's particiation in the study:
Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval > 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR^0.33, RR = 60/heart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) < 50% in the tests and examinations during the screening period; Cerebrovascular Accident; Participants with poorly controlled hypertension on medication, with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg;
Other clinically significant diseases:
HbA1c > 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifunga therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) / non-infectious pneumonia, or current ILD/non-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; History of genital tract fistula, except for whose perforations or fistulas that have been treated with resection or repair, and are considered by the investigator to be healed or in remission; Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Participants in this trial will be randomly assigned to one of two groups.
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| Drug |
Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic cervical cancer, including topotecan (1.2 mg/m^2 of by IV on Days 1 to 5, every 21 days), gemcitabine (1000 mg/m^2 by IV on Days 1 and 8, every 21 days), pemetrexed (500 mg/m^2 by IV on Day 1, every 21 days), or docetaxel (75 mg/m^2 by IV on Day 1, every 21 days). |
|
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
| Up to 3.5 years |
| Disease Control Rate (DCR) | The percentage of participants who experience a best response of CR, PR or stable disease (SD). | Up to 3.5 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier. | Up to 3.5 years |
| Incidence of adverse events | Up to 3.5 years |
| Incidence of Anti-Drug Antibody (ADA) | Up to 3.5 years |
| Blood concentration of SYS6002 | Up to 3.5 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |