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A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors

NCT07448922 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-12

No results posted yet for this study

Summary

This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies.

This study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer.

Study hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.

Conditions

  • Advanced Gynecological Malignancies

Interventions

DRUG

SKB518 for injection

SKB518 12mg/kg q3w

DRUG

Carboplatin (AUC 5)

AUC 5 q3w

DRUG

Bevacizumab

Bevacizumab 15mg/kg q3w

DRUG

SKB518 for injection

SKB518 10mg/kg q3w

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2027-12-31
Completion
2028-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07448922 on ClinicalTrials.gov