Liuying District

Researchers are evaluating the anti-tumor activity and safety of amivantamab, both alone and combined with standard chemotherapy, in people with advanced or metastatic colorectal cancer. This includes assessing the recommended dose when amivantamab is added to chemotherapy. Colorectal cancer is a common cancer worldwide, and this study addresses the role of specific receptors involved in tumor growth and resistance to existing treatments. Participants will receive amivantamab either as a monotherapy or in combination with standard chemotherapy regimens such as mFOLFOX6 or FOLFIRI. Amivantamab is given as an intravenous infusion, with doses adjusted based on body weight and specific cohort assignments. Treatment cycles last 28 days and continue until the study treatment ends or the participant discontinues. The study includes a screening period of up to 28 days before treatment starts. During the study, participants will undergo physical exams, performance status evaluations, laboratory tests, vital sign monitoring, and adverse event tracking to assess safety. Tumor assessments will be performed regularly to evaluate treatment response. The primary outcomes include objective response rates and the number and severity of dose-limiting toxicities and adverse events. The study may last up to several years, with follow-up visits up to 30 days after treatment ends.

Researchers are evaluating the safety, tolerability, and anti-tumor activity of Datopotamab Deruxtecan Dato-DXd alone and combined with other anticancer agents in patients with advanced or metastatic solid tumors. This Phase II, open-label, multicenter study uses a master protocol with independent substudies focused on different tumor types including endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. The study aims to find the recommended Phase II dose and assess efficacy and safety across these varied cancers. Participants receive Dato-DXd as monotherapy or in combination with approved or novel anticancer drugs depending on their specific cancer type and substudy assignment. Treatments include intravenous Dato-DXd alone or combined with agents such as capecitabine, 5-Fluorouracil, prednisoneprednisolone, carboplatin, bevacizumab, volrustomig, rilvegostomig, or cisplatin. The study allows evaluation of various combinations across substudies to understand the drugs role in different cancer settings. During the study, participants undergo regular assessments including tumor measurements, safety evaluations, blood tests for pharmacokinetics and immune response, and specific cancer marker tests like PSA or CA-125 depending on cancer type. Researchers measure outcomes such as objective response rate, progression-free survival, duration of response, and adverse events over approximately one year. Safety follow-up occurs after treatment ends, and participants are monitored closely throughout their involvement, which lasts about one year from treatment start.