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

NCT07341100 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-11

No results posted yet for this study

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

Interventions

DRUG

SKB264

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.

DRUG

Clarithromycin

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

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341100 on ClinicalTrials.gov