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Recurrent or Metastatic Cervical CancerPhase 3NCT07797153

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

A Phase 3 study testing JSKN033, Docetaxel and Topotecan in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent or Metastatic Cervical Cancer
What is being tested?
JSKN033, Docetaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
2 sitesChina
Study dates
Sep 2026to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohua Wu, Doctor contact

086-021-64175590

wu.xh@fudan.edu.cn

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Chunyan Lan, 086-020-87343468, lanchy@sysucc.org.cn

    Chunyan Lan, Doctor

  • Affiliated Cancer Hospital of Fudan University

    Shanghai

    Xiaohua Wu, Doctor, 086-021-64175590, wu.xh@fudan.edu.cn

    Xiaohua Wu, Doctor

Other trials in China

About this study

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

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.

Being tested
JSKN033, Docetaxel, Topotecan, Gemcitabine (GEM), Pemetrexed
Medical subject headings
Recurrence, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN033Drug

    JSKN033 should be administered subcutaneously

  • DocetaxelDrug

    Docetaxel

  • TopotecanDrug

    Topotecan

  • Gemcitabine (GEM)Drug

    Gemcitabine

  • PemetrexedDrug

    Pemetrexed

Study groups in NCT07797153
Study groupRoleWhat they receive
ExperimentalExperimentalJSKN033
Receives: Drug: JSKN033
Active ComparatorActive comparatorInvestigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
Receives: Drug: Docetaxel; Drug: Topotecan; Drug: Gemcitabine (GEM); Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to approximately 27 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 27 months

Secondary outcomes (16)

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

    ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

    Measured: Up to approximately 27 months

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

    DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first

    Measured: Up to approximately 27 months

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

    DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

    Measured: Up to approximately 27 months

  4. PFS evaluated by the Investigator as per RECIST 1.1

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

    Measured: Up to approximately 27 months

  5. ORR evaluated by the Investigator as per RECIST 1.1

    ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

    Measured: Up to approximately 27 months

  6. DoR evaluated by the Investigator as per RECIST 1.1

    DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first

    Measured: Up to approximately 27 months

  7. DCR evaluated by the Investigator as per RECIST 1.1

    DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

    Measured: Up to approximately 27 months

  8. Number and Severity of Treatment-emergent Adverse Events (TEAEs)

    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.

    Measured: Up to approximately 27 months

  9. Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    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.

    Measured: Up to approximately 27 months

  10. Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24)

    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.

    Measured: Up to approximately 27 months

  11. Plasma Concentrations of JSKN003

    Measurement of plasma concentrations of JSKN003.

    Measured: Up to approximately 27 months

  12. Plasma Concentration of Total Antibody

    Measurement of plasma concentration of total antibody.

    Measured: Up to approximately 27 months

  13. Plasma Concentration of Free Payload

    Measurement of plasma concentration of free payload.

    Measured: Up to approximately 27 months

  14. Plasma Concentration of Envotumab

    Measurement of plasma concentration of envotumab.

    Measured: Up to approximately 27 months

  15. Incidence and Titer of Anti-Drug Antibodies

    Assessment of the incidence and titer of anti-drug antibodies, as applicable.

    Measured: Up to approximately 27 months

  16. Incidence and Titer of Neutralizing Antibodies

    Assessment of the incidence and titer of neutralizing antibodies, as applicable.

    Measured: Up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
368 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07797153
Sponsor's protocol ID
JSKN033-301
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
1 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JSKN033, Docetaxel and Topotecan in people with Recurrent or Metastatic Cervical Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Wu, Doctor (086-021-64175590, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 (time frame: Up to approximately 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07797153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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