JSKN033 With Chemotherapy for Advanced Cervical Cancer
Tests JSKN033 plus chemotherapy in adults with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer
Key facts
- Where
- Guangzhou and Hangzhou, ChinaSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cervical cancer that has come back, persisted or spread (FIGO stage IVB) and has had no systemic treatment for that stage.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Cervical cancer that persists, has come back or has spread (FIGO stage IVB), where surgery or radiotherapy meant to remove all of the disease is not possible. Squamous cell, adenocarcinoma or adenosquamous type. At least one lesion that can be measured by RECIST 1.1.
- Earlier treatment
- No earlier systemic therapy for recurrent or metastatic cervical cancer.
Main reasons for not taking part
- Earlier treatment with topoisomerase I inhibitors or antibody-drug conjugates containing them
- Active brain metastasis, or history of brainstem, meningeal or spinal cord metastasis
- History of bone marrow or organ transplant from a donor
- Active autoimmune disease needing systemic treatment, or uncontrolled infection
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Trial code
- NCT07497074
- Record updated
- 27 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Voluntarily participate and sign the informed consent form; Age ≥ 18 years old, male or female; Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1; Expected survival ≥ 3 months; 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:; Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; No prior systemic therapy for recurrent or metastatic cervical cancer; At least one measurable lesion per RECIST 1.1 at baseline; Agree to provide recently archived or fresh tumor tissue samples; Adequate organ function; 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; Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
Exclusion: 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; Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors; Inadequate washout period of previous therapy; Toxicity of previous anti-tumor treatment has not fully or partially recovered; History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis; 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; Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:; Presence of clinically severe respiratory impairment caused by pulmonary disease complications; Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors; Active autoimmune diseases requiring systemic treatment; Uncontrolled infection; History of allogeneic bone marrow or organ transplantation; Known allergy to any component of the study drug/platinum, or history of severe allergic reactions to other antibody drugs; 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; 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); 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; 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; Gastrointestinal abnormalities with obvious clinical manifestations; Significant serous effusion; Pregnant and/or lactating women, or planning to become pregnant during the study period.