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حالة التجربة السريرية NCT07497074 لـ سرطان عنق الرحم هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer المرحلة الثانية ٧٨ علاج مركب

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07497074 مصممة لدراسة علاج لـسرطان عنق الرحم. هذه تجربة تدخُّلية من المرحلة الثانية وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٣ شوال ١٤٤٧ هـ لتجنيد ٧٨ مشاركًا. تقودها Jiangsu Alphamab Biopharmaceuticals Co., Ltd، ومن المتوقع اكتمالها بحلول ٨ محرم ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
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.
وصف مفصل
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...عرض المزيد
العنوان الرسمي

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

الحالات الطبية
سرطان عنق الرحم
معرّفات دراسة أخرى
  • JSKN033-202
NCT معرّف
NCT07497074
تاريخ البدء (فعلي)
2026-04
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2028-06
عدد المشاركين المخطط لهم
٧٨
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
JSKN033
PD-L1
Antibody-Drug Conjugates
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غير عشوائي
نموذج التدخل
تصميم تسلسلي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةSafety 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
تجريبيةSafety 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
تجريبيةDose 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
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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.
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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.
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل

  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
جهة اتصال مركزية للدراسة
جهة اتصال: Chunyan Lan, Dr., 086-020-87343009, [email protected]
2 مواقع الدراسة في 1 بلدان

Guangdong

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

Zhejiang

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