JSKN033 Compared With Chemotherapy for Cervical Cancer That Returned or Spread
Compares JSKN033 with chemotherapy in adults whose cervical cancer returned or spread.
Plain-language title generated from the registry record
Registry title: JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer
Key facts
- Where
- Guangzhou and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- Affiliated Cancer Hospital of Fudan UniversityShanghai, 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
- NCT07797153
- Record updated
- 1 September 2026
- Original description
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.Read full original descriptionShow less
A Randomized, Controlled, Open-Label, Multi-center, Phase III Study of JSKN033 Versus Investigator's Choice of Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Platinum-Based Chemotherapy and PD-1/L1 Inhibitor Therapy
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
Inclusion: Voluntary participation and written informed consent; ≥18 years; ECOG performance status score of 0 or 1; Expected survival of more than 3 months; Histologically or cytologically confirmed recurrent or metastatic cervical cancer; At least one measurable lesion in the baseline; Adequate organ function; Provide primary or metastatic tumor samples; Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.
Exclusion: Other-malignancy diagnosed within 3 years prior to randomization; Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates; Inadequate washout from prior therapy before randomization; Active or prior autoimmune-disease ; Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1; Previous allogeneic bone-marrow or solid organ transplantation; Significant cardiovascular or cerebrovascular disease; History of genital-tract fistula; Uncontrolled infection; History of ≥Grade 3 immune-related adverse events irAEs; Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent; Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse; Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma; Active central nervous system metastases; Baseline imaging showing tumor invasion, compression of, or arising from vital organs; Risk factors for ILD; Clinically-significant gastrointestinal abnormalities; Uncontrolled pleural effusion; Pregnant or lactating female participants, or women planning pregnancy during the study.