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JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer 2상 78 병용 요법

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임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07497074은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 자궁경부암에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 4월 1일부터 가능하며, 78명의 참여자를 모집할 예정입니다. Jiangsu Alphamab Biopharmaceuticals Co., Ltd이(가) 진행하는 이 연구는 2028년 6월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...더 보기
공식 제목

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

질환명
자궁경부암
기타 연구 식별자
  • JSKN033-202
NCT 번호
NCT07497074
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-06
계획된 등록 인원
78
연구종류
중재연구
단계/상
2상
상태
대상자모집전
키워드
JSKN033
PD-L1
Antibody-Drug Conjugates
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Safety 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
실험적Safety 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
실험적Dose 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
주요결과변수
결과변수측정값 설명시간 범위
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.
이차결과변수
결과변수측정값 설명시간 범위
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.
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체

  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
연구 대표 연락처
연락처: Chunyan Lan, Dr., 086-020-87343009, [email protected]
2 1개국에 임상시험 장소

Guangdong

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

Zhejiang

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