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New treatment option for Advanced Gynecological Malignancies
Official title A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
ClinicalTrials.gov ID: NCT07448922
What this study is testing
What is SKB518 for injection?
SKB518 for injection is an investigational medicine, being studied as a potential treatment for advanced gynecological malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Provide signed written informed consent and demonstrate understanding of and agreement to comply with study requirements and the study visit...
- 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...
You likely can't join if
- Participants meeting any of the following criteria will be excluded: Prior/Current Study Experience
- Participation in any other treatment clinical study, except for observational (non-treatment) studies or follow-up periods of treatment studies...
- For participants with ovarian cancer, mixed tumors containing sarcomatous components or borderline ovarian tumors. \- For participants in Cohorts...
- Prior receipt of any of the following treatments: a) Any drug therapy targeting topoisomerase I, including irinotecan, topotecan hydrochloride for...
- Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- Participants meeting any of the following criteria will be excluded: Prior/Current Study Experience
- Participation in any other treatment clinical study, except for observational (non-treatment) studies or follow-up periods of treatment 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...
- 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...
- Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.