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Advanced Gynecological MalignanciesPhase 2NCT07448922

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

A Phase 2 study testing SKB518 for injection, Carboplatin (AUC 5) and Bevacizumab in people with Advanced Gynecological Malignancies, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Gynecological Malignancies
What is being tested?
SKB518 for injection, Carboplatin (AUC 5) and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesChina
Study dates
8 Apr 2026to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Line counting rules for OC are as follows:
  • Adjuvant ± neoadjuvant therapy is considered 1 line of systemic antineoplastic therapy.
  • Maintenance therapy (e.g., bevacizumab, PARP inhibitors) as part of frontline antineoplastic therapy is not counted as a separate line.
  • Treatment regimen changes due to intolerance toxicity rather than disease progression are considered part of the same prior treatment line and are not counted as a separate line.
  • Provide approximately 10-13 unstained consecutive tumor tissue slides during the screening period for gene expression level testing (preferably from recently obtained tissue). If fresh tumor tissue samples are unavailable, archived tumor tissue samples obtained within 2 years prior to first study dose administration may be provided. If a participant is unable to provide archived tumor tissue samples within 2 years prior to first dose, or unable to provide a sufficient number of unstained consecutive tumor tissue slides, the investigator must discuss with the medical monitor to determine whether earlier obtained tumor tissue samples or a reduced number of slides may be accepted. Fine-needle aspiration biopsy specimens or core biopsies are insufficient for biomarker testing. Cell smears from centrifuged thoracic/abdominal/pelvic/pericardial effusion drainage, and bone lesions without soft tissue components or from decalcified bone tumor specimens are also unacceptable.
  • Have at least one target lesion per RECIST v1.1 criteria, accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast preferred) with a longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and the lesion must be suitable for repeated accurate measurement. Lesions located in previously irradiated areas or that have undergone biopsy may serve as measurable target lesions if there is documented evidence of disease progression per RECIST v1.1. Brain lesions are not considered target lesions.
  • Have an estimated life expectancy ≥12 weeks as assessed by the investigator.
  • Demonstrate adequate bone marrow, hepatic, renal, and coagulation function based on laboratory tests performed within 7 days prior to first dose (hematology tests required within 3 days prior to first dose) [supportive treatments, including transfusions, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietin (TPO), TPO receptor agonists (TPO-RA), and interleukins, are not permitted within 14 days prior to first dose]:
  • Hematology: Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥90 g/L;
  • Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤5×ULN; Total bilirubin (TBIL) ≤1.5×ULN and direct bilirubin (DBIL) ≤1.5×ULN;
  • Renal function: Serum creatinine (Cr) ≤1.5×ULN, or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault formula (see Appendix 4); Urinalysis indicating urine protein <2+; for participants with urine protein ≥2+ on baseline urinalysis, a 24-hour urine collection should be performed with protein content <1 g in 24 hours (if both testing methods are used, the 24-hour urine collection value will be used to determine eligibility);
  • Coagulation function: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤1.5×ULN.
  • Have a left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO) within 28 days prior to first study drug administration.
  • Have recovered from all toxicities due to prior therapy (i.e., improved to Grade 0 or 1, or to levels specified in the eligibility criteria). Participants with unresolved, stable chronic (>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.
  • Gender and Contraceptive Requirements
  • Participants must agree to use highly effective contraception during study treatment.
  • Note: The reliability of abstinence as required in the eligibility criteria must be evaluated based on the duration of the clinical study and the participant's preferred and usual lifestyle. Periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, or post-ovulation method) is not an acceptable contraceptive method.
  • Female participants eligible for study participation must be non-pregnant (see Appendix 3), non-lactating, and meet at least one of the following conditions:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3. OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 from the time of informed consent signing through at least 6 months after the last dose of study treatment.

Who cannot join

  • 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.
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  • Prior/Concomitant Therapy
  • Prior receipt of any of the following treatments:
  • 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.
  • Palliative radiotherapy within 2 weeks prior to first drug administration, or definitive radiotherapy within 4 weeks prior to first drug administration.
  • Any condition requiring systemic corticosteroid therapy (dose >10 mg/day prednisolone or equivalent) or other immunosuppressive therapy within 14 days prior to first study drug administration. Participants receiving intranasal, inhaled, topical, or local glucocorticoid injections (e.g., intra-articular injections), or glucocorticoids as prophylaxis for hypersensitivity reactions may be enrolled.
  • Medical Conditions
  • Known symptomatic central nervous system (CNS) metastasis and/or spinal cord compression and/or carcinomatous meningitis, or history of leptomeningeal carcinomatosis. Participants with asymptomatic CNS metastases (no neurological symptoms, no corticosteroid treatment required, and all metastatic lesions ≤1.5 cm in diameter) or with brain metastases that have been treated and are stable may be considered for enrollment if all of the following criteria are met: (a) Measurable disease outside the CNS; (b) No midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastases; (c) Stable condition for at least 4 weeks with no new or enlarging metastases (clearly documented by clinical evidence); (d) Discontinuation of corticosteroids or anticonvulsants at least 2 weeks prior to first study drug administration. CNS lesions should be monitored regularly during the study.
  • History of corticosteroid-treated pneumonitis, or history of other clinically significant pulmonary disease (e.g., interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or participants with suspected such disease on imaging during screening; clinically significant pulmonary function impairment due to concurrent pulmonary disease, including but not limited to: any serious underlying pulmonary disease (e.g., severe asthma, severe chronic obstructive pulmonary disease, or restrictive lung disease), or any autoimmune disease, connective tissue disease, or inflammatory disease potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
  • Presence of the following conditions:
  • Infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first study drug administration; serious infection within 4 weeks prior to first study drug administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
  • Human immunodeficiency virus (HIV) infection, or HIV-positive (HIV 1/2 Ab positive);
  • Acute or chronic active hepatitis B, defined as positive hepatitis B surface antigen (other antigen/antibody results unrestricted) or positive hepatitis B core antibody only (negative hepatitis B surface antibody and negative hepatitis B e antibody), with HBV DNA copy number ≥1×10⁴ copies/mL or ≥2000 IU/mL; acute or chronic active hepatitis C, defined as positive hepatitis C virus (HCV) antibody with HCV RNA titer above the lower limit of detection;
  • Symptomatic coronavirus disease 2019 (COVID-19) infection requiring treatment or resulting in hospitalization, such as fever, dyspnea, nausea, vomiting, diarrhea, etc.;
  • Active tuberculosis infection, or currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to first study drug administration;
  • Active syphilis infection or latent syphilis requiring treatment;
  • Uncontrolled myocarditis, or symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc., QTc interval >480 ms, personal or family history of congenital long/short QT syndrome;
  • Uncontrolled hypertension despite standardized treatment or uncontrolled despite standardized treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
  • Gastrointestinal tract [referring to the muscular tube from mouth to anal canal, including oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal] or tracheal lumen stent implantation;
  • Significant malnutrition, such as requiring intravenous nutritional supplementation due to malnutrition; except if malnutrition was corrected >4 weeks prior to first study treatment.
  • History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to first study drug administration (thrombosis due to implanted venous access ports or catheter-related thrombosis, or superficial venous thrombosis are not considered serious thromboembolism).
  • History of any arterial thromboembolic event within 6 months prior to first study drug administration, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
  • Bleeding within 3 months prior to first study drug administration that was life-threatening, required transfusion, or required invasive treatment.
  • Symptomatic pelvic/abdominal effusion (excluding pelvic/abdominal effusion due to ovarian cancer itself), pleural effusion, or pericardial effusion requiring intervention (participants with stable, controlled effusion are permitted, defined as no significant increase in effusion volume and no clinical symptoms for at least 7 days with drainage tube removed or without drainage).
  • Participants with biliary obstruction unless local treatment for the obstruction has been performed (e.g., endoscopic stent placement or percutaneous transhepatic drainage) and TBIL has decreased to below 1.5×ULN.
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or higher cirrhosis.
  • History of prior gastrointestinal perforation or fistula formation, unhealed gastrointestinal obstruction, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer), participants with recurrent gastrointestinal obstruction (defined as ≥2 episodes of gastrointestinal obstruction within one year, or prior gastrointestinal obstruction in 2 consecutive years), or history of the following conditions: extensive bowel resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • Clinically significant proteinuria.
  • History of severe dry eye, meibomian gland disease (MGD) and/or blepharitis, keratoconjunctivitis sicca (KSC), corneal disorders causing non-healing or delayed healing of the cornea, or macular disorders. Or determination of keratoconjunctivitis and/or corneal ulcer on ophthalmologic examination during screening, and presence of active or chronic corneal disease, other active eye disease requiring continuous treatment, or any clinically significant corneal disease preventing adequate monitoring of drug-induced keratopathy.
  • Known hypersensitivity to study drug or any of its components [including polysorbate 80 (II)], or history of serious allergic reaction to other monoclonal antibodies; known history of platinum hypersensitivity for Cohort C; known history of platinum or bevacizumab hypersensitivity for Cohort D; known history of bevacizumab hypersensitivity for Cohort E; and hypersensitivity to both CT and MRI contrast agents, or inability to undergo contrast-enhanced CT and contrast-enhanced MRI for any reason.
  • History of immunodeficiency disorders, including congenital or acquired immunodeficiency diseases.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Pregnant or lactating women.
  • Tumor History
  • Participants with known other malignancies progressing within the past 5 years or requiring active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ with no evidence of disease recurrence.
  • Tumor invasion of surrounding vital organs or tissues (e.g., mediastinal great vessels, superior and inferior vena cava, pericardium, heart, trachea, esophagus, etc.) and/or risk of gastrointestinal, respiratory, or other fistulas due to any cause.
  • Other Exclusion Criteria
  • Presence of other acute or chronic diseases or laboratory abnormalities that may increase the risk of study participation or administration, or interfere with interpretation of study results; presence of neurological, psychiatric, or social conditions affecting trial compliance, significantly increasing the risk of adverse events, or affecting the participant's ability to provide written informed consent.
  • Acute or chronic diseases or laboratory abnormalities that the investigator judges unsuitable for study participation, or any condition that the investigator believes interferes with evaluation of study drug, participant safety, or interpretation of study results, or any other condition that the investigator believes makes the participant unsuitable for this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoping Jin, PhD contact

86-028-67255165

jinxp@kelun.com

China2 sites, 2 recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Dongling Zou, PhD, 023-65075617, 13570049@qq.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Xiaohua Wu, PhD, 021-64175590, wu.xh@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Being tested
SKB518 for injection, Carboplatin (AUC 5), Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKB518 for injectionDrug

    SKB518 12mg/kg q3w

  • Carboplatin (AUC 5)Drug

    AUC 5 q3w

  • BevacizumabDrug

    Bevacizumab 15mg/kg q3w

  • SKB518 for injectionDrug

    SKB518 10mg/kg q3w

Study groups in NCT07448922
Study groupRoleWhat they receive
SKB518 as monotherapy in advanced ovarian cancerExperimentalSKB518 12mg/kg q3w
Receives: Drug: SKB518 for injection
SKB518 as monotherapy in advanced cervical cancer and endometrial cancerExperimentalNot described
Receives: Drug: SKB518 for injection
SKB518 in combination with Carboplatin in advanced ovarian cancerExperimentalNot described
Receives: Drug: SKB518 for injection; Drug: Carboplatin (AUC 5)
SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancerExperimentalNot described
Receives: Drug: SKB518 for injection; Drug: Carboplatin (AUC 5); Drug: Bevacizumab
SKB518 in combination with Bevacizumab in advanced ovarian cancerExperimentalNot described
Receives: Drug: SKB518 for injection; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Measured: Up to 24 months

  2. Progression Free Survival (PFS)

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Overall Survival (OS)

    Measured: Up to 24 months

  2. Duration of Response (DOR)

    Measured: Up to 24 months

  3. Disease Control Rate

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study start8 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07448922
Sponsor's protocol ID
SKB518-II-03
Status last verified
May 2026
First submitted
27 Feb 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKB518 for injection, Carboplatin (AUC 5) and Bevacizumab in people with Advanced Gynecological Malignancies, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoping Jin, PhD (86-028-67255165, jinxp@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07448922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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