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临床试验 NCT07497074 针对宫颈癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer II期 78 联合疗法

尚未招募
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临床试验NCT07497074旨在研究治疗，主要针对宫颈癌。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月1日开始，预计招募78名患者。该研究由Jiangsu Alphamab Biopharmaceuticals Co., Ltd主导，计划于2028年6月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月27日。
简要概括
The goal of this clinical trial is to learn if the therapy of JSKN033 plus chemotherapy with or with bevacizumab is safe to treat patients with advanced cervical cancer. It will also learn about the antitumor activity and pharmacokinetic/ pharmacodynamic profiles of this therapy.
详细描述
This is an open-label, multicenter, Phase II clinical study conducted in China to evaluate the safety and efficacy of JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab in patients with advanced cervical cancer. The study consists of two phases: a safety run-in phase and a dose expansion phase. Enrolled subjects are patients with persistent, recurrent, or metastatic cervical cancer wh...显示更多
官方标题

A Phase II Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Combination With Platinum-Based Chemotherapy With or Without Bevacizumab in Patients With Advanced Cervical Cancer

疾病
宫颈癌
其他研究标识符
  • JSKN033-202
NCT编号
NCT07497074
实际开始日期
2026-04
最近更新发布
2026-03-27
预计完成日期
2028-06
计划入组人数
78
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
关键词
JSKN033
PD-L1
Antibody-Drug Conjugates
主要目的
治疗方法
分配方式
非随机
干预模型
序贯设计
盲法
无（开放性试验）
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Safety run-in dose cohort 1
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 1 according to protocol
JSKN033
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Platinum
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Bevacizumab
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
实验性Safety run-in dose cohort 2
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at dose level 2 according to protocol
JSKN033
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Platinum
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Bevacizumab
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
实验性Dose expansion cohort
JSKN033 in combination with platinum-based chemotherapy ± bevacizumab administered intravenously at a selected dose level
JSKN033
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Platinum
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Bevacizumab
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
主要终点
结果指标度量标准描述时间框架
Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)
21 days from the first dose
Frequency and severity of Treatment-Related Adverse Events (TRAEs)
21 days from the first dose
Frequency and severity of Serious Adverse Events (SAEs)
21 days from the first dose
Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
次要终点
结果指标度量标准描述时间框架
Disease Control Rate (DCR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
Time to Response (TTR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months
Duration of Response (DoR)
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
Progression-Free Survival (PFS) as assessed by the investigator and IRC per RECIST 1.1
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
Overall Survival (OS)
Assessed at approximately 24 months
Maximum plasma concentration (Cmax) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Time to Cmax (Tmax) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Trough concentration (Ctrough) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Area under the plasma concentration-time curve of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Volume of distribution (Vz/F) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Elimination half-life (t1/2) and clearance (CL/F) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Accumulation index of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Mean residence time of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
Incidence of anti-drug antibodies (ADA) of JSKN033
From the enrollment until the end of study. Assessed up to 24 months.
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部

  1. Voluntarily participate and sign the informed consent form.

  2. Age ≥ 18 years old, male or female.

  3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

  4. Expected survival ≥ 3 months.

  5. Histologically or cytologically confirmed persistent, recurrent, or metastatic (FIGO stage IVB) cervical cancer unsuitable for curative surgery and/or curative radiotherapy, meeting the following criteria:

    1. Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
    2. No prior systemic therapy for recurrent or metastatic cervical cancer.

  6. At least one measurable lesion per RECIST 1.1 at baseline.

  7. Agree to provide recently archived or fresh tumor tissue samples.

  8. Adequate organ function.

  9. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.

  10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

  1. Complicated with other malignant tumors within 3 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk.
  2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
  3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.
  4. Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors.
  5. Inadequate washout period of previous therapy.
  6. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
  7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
  8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
  9. Gastrointestinal abnormalities with obvious clinical manifestations.
  10. Significant serous effusion.
  11. Active autoimmune diseases requiring systemic treatment.
  12. Uncontrolled infection.
  13. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
  14. History of allogeneic bone marrow or organ transplantation.
  15. Known allergy to any component of the study drug/platinum, or history of severe allergic reactions to other antibody drugs.
  16. Pregnant and/or lactating women, or planning to become pregnant during the study period.
  17. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
  18. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.
  19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and/or uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count > 20×10⁹/L), cachexia manifestations, etc.
  20. Known contraindications to bevacizumab or allergy to its components, or the medical conditions affecting its safe use (Note: Applicable only to subjects planned to receive bevacizumab).
Jiangsu Alphamab Biopharmaceuticals Co., Ltd logoJiangsu Alphamab Biopharmaceuticals Co., Ltd
研究中心联系人
联系人: Chunyan Lan, Dr., 086-020-87343009, [email protected]
2 位于 1 个国家/地区的研究中心

Guangdong

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China
Chunyan Lan, 联系人, 086-020-87343468, [email protected]

Zhejiang

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310032, China
Hanmei Lou, 联系人, 086-0571-88122146, [email protected]