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

ClinicalTrials.gov ID

NCT07797153

Lead Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., LtdINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

368Estimated

Last Update Posted

Sep 1, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

Official Title

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

Brief 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.

• Recurrent or Metastatic Cervical Cancer

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., LtdINDUSTRY

wu.xh@fudan.edu.cn086-021-64175590

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