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)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Affiliated Cancer Hospital of Fudan University
Shanghai
China
More Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials in China
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.
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