Can a new drug outperform chemotherapy in Hard-to-Treat cervical cancer?

NCT ID NCT07797153

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial compares an experimental drug called JSKN033 with standard chemotherapy in people whose cervical cancer has returned or spread and no longer responds to platinum-based chemotherapy or PD-1/L1 inhibitors. The study includes about 368 adults with recurrent or metastatic cervical cancer. Participants receive either JSKN033 or one of several chemotherapy options chosen by their doctor. The main goals are to see if JSKN033 extends the time before the cancer grows and improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JSKN033, an experimental drug given as a subcutaneous injection
What this could lead to
If successful, JSKN033 could offer a new treatment option for people with advanced cervical cancer who have run out of standard therapies.
What could go wrong
This is a phase III trial, but the drug is still experimental. It may not improve survival or could cause side effects. Results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 368 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Recurrence Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Fudan University

    Shanghai, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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