Mount Kuring Gai

Researchers are evaluating the effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) in people with various recurrent or metastatic solid tumors. These include cancers such as endometrial, head and neck squamous cell carcinoma, pancreatic, colorectal, hepatocellular, esophageal, gastroesophageal junction and stomach adenocarcinoma, urothelial, ovarian, cervical, biliary tract, HER2-low and HER2-negative breast cancer, and cutaneous melanoma. The study is a Phase 1B/2 open-label trial designed to observe how well I-DXd works and how safe it is in these cancer types, especially in patients who have received prior systemic treatments. Treatment involves intravenous administration of ifinatamab deruxtecan. The study is divided into two parts, Stage 1 and Stage 2, with each tumor type cohort starting at Stage 1 and potentially moving to Stage 2 if safety and effectiveness data support continuation. There is also a special safety run-in phase for hepatocellular carcinoma participants to assess tolerability before proceeding further. Participants will undergo regular assessments including imaging scans to measure tumor response and biopsies for tissue analysis. Safety is closely monitored by tracking adverse events and dose-limiting toxicities, especially during the initial treatment cycles. Researchers will measure outcomes such as objective response rate from the first dose until disease progression or other endpoints, with safety follow-up extending up to about 57 months. Participants will be evaluated for overall health, liver function, and tumor progression throughout the study to gather comprehensive data on treatment effects and tolerability.

Researchers are evaluating the safety and effectiveness of PF-06835375, a CXCR5 inhibitor, in adults with moderate to severe primary immune thrombocytopenia (ITP), a condition where low platelet counts can cause bleeding problems. This Phase 2, open-label, multicenter study focuses on participants who have had persistent ITP for more than 3 months but less than or equal to 12 months, or chronic ITP for more than 12 months. The goal is to understand how PF-06835375 affects platelet levels and to assess its potential benefits and risks. Participants receive monthly subcutaneous injections of PF-06835375. Those in cohort 1 get one injection of dose 1 every month for 3 months during a 12-week treatment period. Participants in cohorts 2, 3, or 4 receive doses 2, 3, or 4, respectively, each month for 4 months during a 16-week treatment period. These dosing schedules aim to maintain enough exposure to reduce CXCR5 positive cells and potentially increase platelet counts by also affecting Tfh cells. Throughout the study, researchers will monitor changes in platelet counts from the start through weeks 12 and 16. Participants will be regularly assessed for safety and how their platelet levels respond to treatment. The study will track any bleeding events and other health changes to evaluate the treatment's overall impact over the treatment periods.