New drug combo targets recurrent ovarian cancer in small trial

NCT ID NCT07341100

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a new drug called SKB264, given by IV every two weeks, in 20 women with recurrent ovarian epithelial cancer. It also looks at how the antibiotic clarithromycin affects SKB264 levels in the body. The main goals are to see if the drug shrinks tumors and to understand its safety and drug interactions.

What this could mean

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

Active substance
SKB264 (a drug given by IV) and clarithromycin (an antibiotic taken by mouth)
What this could lead to
If it works, this could point toward a new treatment option for recurrent ovarian cancer.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Started

Jan 2026

Expected to finish

Jun 2028

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 to 75 years

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: 1. Females, ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF). 2. Patients with histologically or cytologically confirmed recurrent ovarian epithelial cancer (including fallopian tube cancer or primary peritoneal cancer). 3. Able to provide tumor tissue samples. 4. At least one measurable lesion. 5. ECOG performance status score of 0 or 1. 6. Life expectancy ≥ 12 weeks. 7. Adequate bone marrow, liver, kidney, and coagulation function. 8. Female participants of childbearing potential must agree to use effective medical contraception from the time of signing the ICF until 6 months after the last dose. 9. The participant voluntarily agrees to participate in the study, signs the ICF, and is able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 1. Participants with local recurrence who are suitable for surgery. 2. Participants who have previously undergone bone marrow radiation. 3. Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer of non-epithelial origin, or other pathological types. 4. Participants with known brain metastases. 5. History of other malignancies within 3 years before the first administration. 6. There are serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 7. Uncontrolled systemic disease as judged by the investigator. 8. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy. 9. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of severe corneal disorder that prevents/delays corneal healing. 10. Patients with serious pulmonary function impairment due to lung disease. 11. Participants with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal hemorrhage. 12. Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism, or excretion of the oral study drug . 13. Risk of developing an esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels with associated symptoms. 14. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1. 15. Subjects with known active pulmonary tuberculosis. 16. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant. 17. Active hepatitis B or hepatitis C. 18. Positive human immunodeficiency virus (HIV) test or a history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 19. Known hypersensitivity to any study drug or any of its components , or known severe hypersensitivity reactions to other biological agents. 20. Major surgery within 4 weeks before the first dose or expected to require major surgery during the study. 21. Serious infection within 4 weeks before the first dose. 22. Prior treatment with TROP2-targeted drug therapy or prior treatment with another topoisomerase I inhibitor as the toxin. 23. Have received any drugs that can affect CYP3A enzyme activity within 2 weeks before the first dose or within 5 half-lives of the known drug. 24. Have received any systemic anti-tumor therapy such as chemotherapy, radiotherapy , immunotherapy, targeted therapy, or biological therapy within 4 weeks before the first dose or within 5 half-lives of the known drug. 25. Have received treatment with approved traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before the first dose. 26. Have received a live vaccine within 4 weeks before the first dose, or plan to receive a live vaccine during the study. 27. Any disease requiring systemic glucocorticoid therapyor other immunosuppressive drugs within 2 weeks before the first dose. 28. Participants who are currently participating in other clinical studies and receiving study drug. 29. Pregnant or lactating women. 30. Participants whose condition deteriorates rapidly before the first dose. 31. Presence of local or systemic diseases caused by non-malignant tumors. 32. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study drug or the participant's safety or the interpretation of the study results, or any other condition that the investigator deems inappropriate for participation in this study.

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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.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou, 510050, China

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