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

NCT07797153 | Not Yet Recruiting Phase 3

• 1 other identifier: JSKN033-301
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent or Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1

  PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first

  Up to approximately 27 months

• Overall Survival (OS)

  OS was defined as the time from randomization until the date of death from any cause

  Up to approximately 27 months

Secondary Outcomes (16)

• Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 27 months

• Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 27 months

• Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 27 months

• PFS evaluated by the Investigator as per RECIST 1.1

  Up to approximately 27 months

• ORR evaluated by the Investigator as per RECIST 1.1

  Up to approximately 27 months

Study Arms (2)

Experimental

EXPERIMENTAL

JSKN033

Drug: JSKN033

Active Comparator

ACTIVE COMPARATOR

Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.

Drug: Docetaxel; Drug: Topotecan; Drug: Gemcitabine (GEM); Drug: Pemetrexed

Interventions

JSKN033 DRUG

JSKN033 should be administered subcutaneously

Experimental

Docetaxel DRUG

Docetaxel

Active Comparator

Topotecan DRUG

Topotecan

Active Comparator

Gemcitabine (GEM) DRUG

Gemcitabine

Active Comparator

Pemetrexed DRUG

Pemetrexed

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Affiliated Cancer Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Interventions

Docetaxel; Topotecan; Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Xiaohua Wu, Doctor

CONTACT

086-021-64175590; wu.xh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (2)