New hope for advanced cervical cancer: experimental drug combo enters trial
NCT ID NCT07497074
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the experimental drug JSKN033 to standard chemotherapy (with or without bevacizumab) is safe and effective for people with advanced cervical cancer that has spread or come back. About 78 adults will take part. The goal is to control the disease and measure tumor shrinkage, not to cure it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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