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Starting soon Phase 3

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

NCT07797153 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-09
Last updated
2026-09-01

Condition(s) studied

Recurrent or Metastatic Cervical Cancer

Investigational drug(s) / intervention(s)

JSKN033 →Docetaxel →Topotecan →Gemcitabine (GEM) →Pemetrexed →

JSKN033: JSKN033 should be administered subcutaneously

Docetaxel: Docetaxel

Topotecan: Topotecan

Gemcitabine (GEM): Gemcitabine

Pemetrexed: Pemetrexed

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Affiliated Cancer Hospital of Fudan University Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07797153 on ClinicalTrials.gov ↗ ← All trials in China