ctDNA Methylation for Detecting Ovarian Cancer
Epithelial Ovarian CancerCirculating Tumor DNA7 moreOvarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab
Recurrent Ovarian CancerThe study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.
A Phase 1 Study to Evaluate Paclitaxel Conjugated CXC Receptor 4 Antagonist (MB1707) in Patients...
Advanced Solid TumorBreast Cancer3 moreThe study will evaluate the pharmacokinetics (PK) and safety of a single intravenous (IV) dose of 0.3 mg/kg MB1707 in patients with advanced cancers.
Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian...
Ovarian CancerThis prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery , adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the study. All patients will be closely monitored through out the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125, HE4, CEA, CA199, and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.
Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual...
Epithelial Ovarian CancerBlood samples and Tumor tissue will be collected at certain timepoints and will be tested.
A Non-interventional Registry Study of Fluzoparib in the Treatment of Ovarian Cancer
Ovarian CancerOvarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis. This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.
Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer
Epithelial Ovarian CancerEXCYTE-1 is a multicentre, prospective observational study to investigate the relationship between ex vivo drug response (EVDR), measured in ovarian tumour-derived samples using high content imaging, and actual patient clinical response. Patients with newly diagnosed or relapsed/refractory epithelial ovarian carcinoma, that present with malignant effusions (ascites or pleural effusions), will be enrolled in the study before starting their initial or next treatment line. Enrolled patients will be asked to provide ascites, peripheral blood and fresh tumour tissue if available. Samples will be shipped to the sponsor laboratory and their response to standard of care drugs evaluated ex vivo. Participants will: provide samples during routine clinical procedures agree that data about their medical history, diagnosis and health status at the following timepoints are collected: at signature of the consent form, at the time samples are provided, at start of the therapy, upon completion of the therapy, regularly after completion of the therapy
First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian...
Ovarian CancerHigh Grade Serous Adenocarcinoma of Ovary3 moreThis is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+...
Breast CancerOvarian Cancer6 moreThe goal of this interventional clinical trial is to learn about TNG348, a ubiquitin specific peptidase 1 (USP1) inhibitor, alone and in combination with olaparib in patients with BRCA 1/2 mutant or HRD+ solid tumors. The main question[s] it aims to answer are: to evaluate the safety and tolerability of single agent and combination therapy to determine the recommended dose for Phase 2 of single agent and combination therapy to determine the pharmacokinetics of TNG348 as a single agent and in combination therapy to evaluate the initial antineoplastic activity as a single agent and in combination therapy Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.
A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid...
Solid TumorAdult21 moreThe goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose of A2B694 that is safe for patients Phase 2: Does the recommended dose of A2B694 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen A2B694 Tmod CAR T cells at the assigned dose