SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Официальное название

A Randomized, Open-Label, Controlled, Multicenter Phase 3 Trial of SYS6002 Versus Chemotherapy of Physician's Choice in Recurrent or Metastatic Cervical Cancer After Platinum-containing Chemotherapy and Anti-PD-(L)1 Agent Therapy

Обзор

This study is a randomized, open-label, controlled, multicenter phase Ⅲ 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

Вмешательства

• Препарат SYS6002
  SYS6002，intravenous injection
• Препарат Investigator's Choice of Chemotherapy
  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).

Первичные конечные точки

• Overall Survival [Срок оценки: Up to 3.5 years]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) [Срок оценки: Up to 3.5 years]
• Duration of Response (DOR) [Срок оценки: Up to 3.5 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 3.5 years]
• Progression Free Survival (PFS) [Срок оценки: Up to 3.5 years]
• Incidence of adverse events [Срок оценки: Up to 3.5 years]
• Incidence of Anti-Drug Antibody (ADA) [Срок оценки: Up to 3.5 years]
• Blood concentration of SYS6002 [Срок оценки: Up to 3.5 years]

Критерии участия

Критерии включения

• 1\. Patients aged 18-75 years (inclusive);
• 2\. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent;
• 3\. Subject must have received a platinum-based chemotherapy with anti-PD-(L)1 agent and if was received administered in the adjuvant/neoadjuvant setting subject must have progressed during treatment or within 6 months of treatment completion；received no more than 2 prior systemic therapy in the metastatic/recurrent setting; must have experienced radiographic progression during or after the last treatment regimen;
• 4\. An archival tumor tissue sample or a fresh tissue sample should be provided;
• 5\. Subjects must have measurable disease according to RECIST (version 1.1);
• 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• 7\. Life expectancy of ≥ 3 months;
• 8\. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;
• 9.Sexually active fertile subjects must agree to use methods of contraception during the study and at least7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;
• 10.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

Критерии исключения

• 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;

• 5\. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;
• 6\. Allergy to any component of SYS6002, or humanized monoclonal antibodies;
• 7\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07230626 · SYS6002-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗