Can a new drug outperform chemotherapy in Hard-to-Treat cervical cancer?
NCT ID NCT07797153
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Recurrent or metastatic cervical cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Hormone-Blocking drug boost chemo against cervical cancer?
- Could a Two-Drug combo outsmart advanced cervical cancer?
- New drug combo targets advanced cervical cancer
- Immune cells from your own tumor could fight cervical cancer
- Triple-Drug cocktail takes on recurrent gynecologic cancers
- New hope for Hard-to-Treat cervical cancer? drug trial targets HER2