Platinum-resistant Ovarian Cancer (PROC)

This is a Phase 1 study to assess safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ARR-002 in advanced or metastatic ovarian or endometrial cancer.

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This project plans to conduct a prospective, multicenter clinical study. The intended participants are patients with histologically confirmed advanced (FIGO III/IV stage) ovarian serous carcinoma, ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma who have platinum-resistant recurrence or are platinum-refractory (n=30). The study design is a single-arm study. The treatment regimen for the study group is the RIF combined with anlotinib group, with continuous administration until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or study termination, whichever occurs first. The treatment duration will not exceed 18 months, with a follow-up period of 24 months. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life score (QOL), and safety. The primary efficacy evaluation will use imaging methods (RECIST 1.1) combined with tumor marker CA125 levels. All data in this study will be summarized using appropriate statistical measures based on data type: continuous data will be described using mean, standard deviation (STD), median, minimum, and maximum, while categorical data will be summarized using frequency and percentage (proportion). Time-to-event data will be analyzed using the Kaplan-Meier (KM) product-limit method to estimate median survival time, with survival curves plotted and 95% confidence intervals for median time estimated when necessary. This study aims to evaluate the efficacy and safety of RIF combined with anlotinib in patients with platinum-resistant recurrent ovarian cancer, providing a new therapeutic strategy.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus Non-platinum chemotherapy and Fuzuloparib (PARP inhibitor) induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib in platinum-resistant relapsed/metastatic ovarian cancer.