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Ovarian Epithelial CancerPhase 2NCT07341100

Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin on the PK of SKB264 in OC

A Phase 2 study testing SKB264 and Clarithromycin in people with Ovarian Epithelial Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, open-label study to evaluate the preliminary efficacy of SKB264 and the effect of clarithromycin on the PK of SKB264 in patients with ovarian epithelial cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Epithelial Cancer
What is being tested?
SKB264 and Clarithromycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
16 Jan 2026to Jun 2028
Phase
Phase 2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females, ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF).
  • Patients with histologically or cytologically confirmed recurrent ovarian epithelial cancer (including fallopian tube cancer or primary peritoneal cancer).
  • Able to provide tumor tissue samples.
  • At least one measurable lesion.
  • ECOG performance status score of 0 or 1.
  • Life expectancy ≥ 12 weeks.
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  • Adequate bone marrow, liver, kidney, and coagulation function.
  • 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.
  • 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.

Who cannot join

  • Participants with local recurrence who are suitable for surgery.
  • Participants who have previously undergone bone marrow radiation.
  • Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer of non-epithelial origin, or other pathological types.
  • Participants with known brain metastases.
  • History of other malignancies within 3 years before the first administration.
  • There are serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
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  • Uncontrolled systemic disease as judged by the investigator.
  • History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy.
  • Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of severe corneal disorder that prevents/delays corneal healing.
  • Patients with serious pulmonary function impairment due to lung disease.
  • Participants with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal hemorrhage.
  • Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism, or excretion of the oral study drug .
  • Risk of developing an esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels with associated symptoms.
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
  • Subjects with known active pulmonary tuberculosis.
  • Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.
  • Active hepatitis B or hepatitis C.
  • Positive human immunodeficiency virus (HIV) test or a history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
  • Known hypersensitivity to any study drug or any of its components , or known severe hypersensitivity reactions to other biological agents.
  • Major surgery within 4 weeks before the first dose or expected to require major surgery during the study.
  • Serious infection within 4 weeks before the first dose.
  • Prior treatment with TROP2-targeted drug therapy or prior treatment with another topoisomerase I inhibitor as the toxin.
  • 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.
  • 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.
  • Have received treatment with approved traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before the first dose.
  • Have received a live vaccine within 4 weeks before the first dose, or plan to receive a live vaccine during the study.
  • Any disease requiring systemic glucocorticoid therapyor other immunosuppressive drugs within 2 weeks before the first dose.
  • Participants who are currently participating in other clinical studies and receiving study drug.
  • Pregnant or lactating women.
  • Participants whose condition deteriorates rapidly before the first dose.
  • Presence of local or systemic diseases caused by non-malignant tumors.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou, 510050

Other trials in China

About this study

Official title: A Multicenter, Open-label Clinical Study to Evaluate the Preliminary Efficacy of SKB264 and the Effect of Clarithromycin, a Potent CYP3A Inhibitor, on the Pharmacokinetics of SKB264 in Patients With Ovarian Epithelial Cancer

This is a multicenter, open-label study to evaluate the preliminary efficacy of SKB264 and the effect of clarithromycin on the PK of SKB264 in patients with ovarian epithelial cancer.

Read the detailed description

Cycle 1 will be for drug-drug interaction (DDI) assessment. Thereafter, participants will receive SKB264 monotherapy.

Being tested
SKB264, Clarithromycin
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • SKB264Drug

    4 mg/kg, administered once every 2 weeks (Q2W) by intravenous infusion. It will be administered on Day 1 and Day 17 of Cycle 1, and from Cycle 2 onwards, on Day 1 and Day 15 of each 4-week cycle.

  • ClarithromycinDrug

    500 mg administered orally, twice daily (BID) from Day 14 to Day 29 of Cycle 1.

Study groups in NCT07341100
Study groupRoleWhat they receive
SKB264+clarithromycinExperimentalCycle 1 will be for drug-drug interaction (DDI) assessment participants received SKB264 and clarithromycin .Thereafter, participants will receive SKB264 monotherapy
Receives: Drug: SKB264; Drug: Clarithromycin

What is being measured

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

  1. Efficacy Endpoint

    Objective response rate (ORR) assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: From the date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. Maximum observed plasma concentration (Cmax)of SKB264-ADC,SKB264-TAB and free KL610023

    To assess the pharmacokinetic (PK) profile of SKB264

    Measured: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles（Starting from the second cycle, each cycle is 28 days ），up to approximately 12 months

  3. Area under plasma/serum concentration-time curve from zero to 13 day（AUC0-13d）of SKB264-ADC,SKB264-TAB and free KL610023

    To assess the pharmacokinetic (PK) profile of SKB264

    Measured: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles（Starting from the second cycle, each cycle is 28 days ），up to approximately 12 months

  4. Area under plasma/serum concentration-time curve from zero to infinity（AUC0-∞）of SKB264-ADC, SKB264-TAB, and free KL610023

    To assess the pharmacokinetic (PK) profile of SKB264

    Measured: The first cycle lasts for 30 days each day, and the first day of the second, third, sixth, and twelfth cycles（Starting from the second cycle, each cycle is 28 days ），up to approximately 12 months

Timeline

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

  1. First posted14 Jan 2026
  2. Study start16 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJun 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07341100
Sponsor's protocol ID
SKB264-Ⅱ-19
Status last verified
May 2026
First submitted
18 Dec 2025
Last updated
1 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKB264 and Clarithromycin in people with Ovarian Epithelial Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site 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 32 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Endpoint (time frame: From the date of first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). The study lists 4 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 NCT07341100.

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 Jun 2026.

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