NCT07448922

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Sep 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

February 27, 2026

Last Update Submit

May 7, 2026

Conditions

Advanced Gynecological Malignancies

Outcome Measures

Primary Outcomes (2)

  • Objective Response Rate (ORR)

    Up to 24 months

  • Progression Free Survival (PFS)

    Up to 24 months

Secondary Outcomes (3)

  • Overall Survival (OS)

    Up to 24 months

  • Duration of Response (DOR)

    Up to 24 months

  • Disease Control Rate

    Up to 24 months

Study Arms (5)

SKB518 as monotherapy in advanced ovarian cancer

EXPERIMENTAL

SKB518 12mg/kg q3w

Drug: SKB518 for injection

SKB518 as monotherapy in advanced cervical cancer and endometrial cancer

EXPERIMENTAL
Drug: SKB518 for injection

SKB518 in combination with Carboplatin in advanced ovarian cancer

EXPERIMENTAL
Drug: SKB518 for injectionDrug: Carboplatin (AUC 5)

SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer

EXPERIMENTAL
Drug: SKB518 for injectionDrug: Carboplatin (AUC 5)Drug: Bevacizumab

SKB518 in combination with Bevacizumab in advanced ovarian cancer

EXPERIMENTAL
Drug: SKB518 for injectionDrug: Bevacizumab

Interventions

Carboplatin (AUC 5)DRUG

AUC 5 q3w

SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancerSKB518 in combination with Carboplatin in advanced ovarian cancer
BevacizumabDRUG

Bevacizumab 15mg/kg q3w

SKB518 in combination with Bevacizumab in advanced ovarian cancerSKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer
SKB518 for injectionDRUG

SKB518 12mg/kg q3w

SKB518 as monotherapy in advanced cervical cancer and endometrial cancerSKB518 as monotherapy in advanced ovarian cancerSKB518 in combination with Bevacizumab in advanced ovarian cancerSKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancerSKB518 in combination with Carboplatin in advanced ovarian cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide signed written informed consent and demonstrate understanding of and agreement to comply with study requirements and the study visit schedule.
  • Age
  • Be ≥ 18 years and ≤ 75 years of age at the time of informed consent signing.
  • Participant Type and Disease Characteristics
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 2 weeks prior to first dose administration.
  • Have a cytologically or histologically confirmed gynecologic malignancy.
  • Cohort A: Ovarian cancer (OC) (including fallopian tube cancer and primary peritoneal cancer) with epithelial ovarian carcinoma histology, previously treated with 2-4 lines of systemic therapy, excluding primary platinum-resistant ovarian cancer (defined as disease recurrence or progression during first-line platinum-containing therapy, or disease recurrence or progression occurring \<182 days from the last platinum-containing therapy in the first line).
  • Cohort B: Cervical cancer or endometrial cancer that has failed standard therapy or is intolerant to standard therapy, or for which no standard therapy exists.
  • Cohort C: Platinum-sensitive ovarian cancer (PSOC) previously treated with 2-4 lines of systemic therapy.
  • Cohort D: PSOC previously treated with 1-2 lines of systemic therapy.
  • Cohort E Safety Lead-in Phase: PSOC previously treated with 2-4 lines of systemic therapy.
  • Cohort E Expansion Phase: PSOC participants who have achieved Complete Response (CR),Partial Response (PR), or Stable Disease (SD) after 2 lines of therapy (platinum-based doublet regimen combined with bevacizumab), and require randomization within 8 weeks after the last dose.
  • Participants in Cohorts A, C, D, and E with known breast cancer susceptibility gene (BRCA) mutations must have received poly(ADP-ribose) polymerase (PARP) inhibitor therapy, unless contraindicated.
  • Note:
  • PSOC is defined as radiographic progression/recurrence occurring ≥6 months after the last platinum-containing chemotherapy, i.e., the interval from the date of the last platinum therapy to radiographic evidence of disease progression per RECIST v1.1 should be ≥6 months (182 days).
  • +20 more criteria

You may not qualify if:

  • Participants meeting any of the following criteria will be excluded:
  • Prior/Current Study Experience
  • Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up periods of interventional studies.
  • Disease Characteristics
  • For participants with ovarian cancer, mixed tumors containing sarcomatous components or borderline ovarian tumors.
  • \- For participants in Cohorts C-E, mixed tumors containing high-grade serous carcinoma components and other components, or endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of the above histological types, or low-grade/borderline ovarian tumors.
  • Prior/Concomitant Therapy
  • Prior receipt of any of the following treatments:
  • a) Any drug therapy targeting topoisomerase I, including irinotecan, topotecan hydrochloride for injection, antibody-drug conjugates (ADCs) containing topoisomerase I, etc.
  • Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy, etc. For oral PARP inhibitors and traditional Chinese medicines indicated for antineoplastic therapy, the washout period is 2 weeks or 5 half-lives, whichever is longer.
  • Receipt of strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors (see Appendix 8) within 2 weeks prior to first dose or within 5 half-lives of the known drug, whichever is longer.
  • Receipt of live vaccine vaccination within 4 weeks prior to first study drug administration, or planned receipt of any live vaccine during the study.
  • Persistence of adverse reactions from prior antineoplastic therapy that have not resolved to Grade 0, Grade 1, or baseline status per NCI-CTCAE v5.0 criteria prior to first study drug administration. Participants with unresolved, stable chronic (\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.
  • Major surgery (craniotomy, thoracotomy, or laparotomy, and other surgical types considered "major" by the investigator, excluding needle biopsy) within 4 weeks prior to first study drug administration, or anticipated major surgery during the study, or presence of serious unhealed wounds, trauma, or ulcers, etc.
  • Note: Palliative local surgical treatment for isolated lesions is acceptable.
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chongqing University Cancer Hospital

Chongqing, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

InjectionsCarboplatinBevacizumab

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsCoordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Xiaoping Jin, PhD

CONTACT

86-028-67255165jinxp@kelun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

April 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)