JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer

• JSKN033 (Drug): JSKN033 should be administered subcutaneously
• Docetaxel (Drug): Docetaxel
• Topotecan (Drug): Topotecan
• Gemcitabine (GEM) (Drug): Gemcitabine
• Pemetrexed (Drug): Pemetrexed

Primary outcomes

• Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 [Up to approximately 27 months]: PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
• Overall Survival (OS) [Up to approximately 27 months]: OS was defined as the time from randomization until the date of death from any cause

Secondary outcomes

• Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1 [Up to approximately 27 months]: ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
• Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1 [Up to approximately 27 months]: DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
• Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1 [Up to approximately 27 months]: DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
• PFS evaluated by the Investigator as per RECIST 1.1 [Up to approximately 27 months]: PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
• ORR evaluated by the Investigator as per RECIST 1.1 [Up to approximately 27 months]: ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
• DoR evaluated by the Investigator as per RECIST 1.1 [Up to approximately 27 months]: DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
• DCR evaluated by the Investigator as per RECIST 1.1 [Up to approximately 27 months]: DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
• Number and Severity of Treatment-emergent Adverse Events (TEAEs) [Up to approximately 27 months]: The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
• Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Up to approximately 27 months]: Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). All scores are transformed to a 0-100 scale. Higher scores represent better function/global quality-of-life status for functional and global health scales, and worse symptom burden for symptom scales.
• Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24) [Up to approximately 27 months]: Patient-reported quality-of-life assessments using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24). All scores are transformed to a 0-100 scale; higher scores indicate worse outcomes for symptom scales, except for sexual activity and sexual enjoyment items where higher scores indicate better outcomes.
• Plasma Concentrations of JSKN003 [Up to approximately 27 months]: Measurement of plasma concentrations of JSKN003.
• Plasma Concentration of Total Antibody [Up to approximately 27 months]: Measurement of plasma concentration of total antibody.
• Plasma Concentration of Free Payload [Up to approximately 27 months]: Measurement of plasma concentration of free payload.
• Plasma Concentration of Envotumab [Up to approximately 27 months]: Measurement of plasma concentration of envotumab.
• Incidence and Titer of Anti-Drug Antibodies [Up to approximately 27 months]: Assessment of the incidence and titer of anti-drug antibodies, as applicable.
• Incidence and Titer of Neutralizing Antibodies [Up to approximately 27 months]: Assessment of the incidence and titer of neutralizing antibodies, as applicable.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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 Criteria:

* Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma.
* Other-malignancy diagnosed within 3 years prior to randomization.
* Active central nervous system metastases.
* Baseline imaging showing tumor invasion, compression of, or arising from vital organs.
* Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates.
* Inadequate washout from prior therapy before randomization.
* Risk factors for ILD.
* Significant cardiovascular or cerebrovascular disease.
* Clinically-significant gastrointestinal abnormalities.
* History of genital-tract fistula.
* Uncontrolled pleural effusion.
* Active or prior autoimmune-disease .
* Uncontrolled infection.
* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
* History of ≥Grade 3 immune-related adverse events irAEs.
* Previous allogeneic bone-marrow or solid organ transplantation.
* Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent.
* Pregnant or lactating female participants, or women planning pregnancy during the study.
* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.