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

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07448922
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Gynecological Malignancies

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SKB518 for injection — DRUG
    SKB518 12mg/kg q3w
  • Carboplatin (AUC 5) — DRUG
    AUC 5 q3w
  • Bevacizumab — DRUG
    Bevacizumab 15mg/kg q3w
  • SKB518 for injection — DRUG
    SKB518 10mg/kg q3w

Study Details

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.

Key Dates

First listed
Mar 4, 2026
Start date
Apr 8, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SKB518 as monotherapy in advanced ovarian cancer
    SKB518 12mg/kg q3w
  • Experimental: SKB518 as monotherapy in advanced cervical cancer and endometrial cancer
  • Experimental: SKB518 in combination with Carboplatin in advanced ovarian cancer
  • Experimental: SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer
  • Experimental: SKB518 in combination with Bevacizumab in advanced ovarian cancer

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts