New drug combo targets recurrent ovarian cancer in small trial
NCT ID NCT07341100
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 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: 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fallopian tube 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.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, 510050, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, randomized, open-label phase III study of IBI354 versus Investigator's choice of chemotherapy in patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
- Can a targeted drug duo hold off ovarian cancer's return?
- Can a maintenance drug extend remission in ovarian cancer? a large Real-World study investigates
- Can a Dual-Antibody combo hold ovarian cancer at bay longer?
- Can a targeted drug keep ovarian cancer at bay longer?
- Can a new drug shrink Hard-to-Treat gynecological tumors?