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

NCT07341100 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-Ⅱ-19
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (4)

• Efficacy Endpoint

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

  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

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

  To assess the pharmacokinetic (PK) profile of SKB264

  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

• 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

  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

• 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

  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

Study Arms (1)

SKB264+clarithromycin

EXPERIMENTAL

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

Drug: SKB264; Drug: Clarithromycin

Interventions

SKB264 DRUG

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.

SKB264+clarithromycin

Clarithromycin DRUG

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

SKB264+clarithromycin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01