Mount Kuring Gai

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

Researchers are studying GDC-7035, a drug being tested alone and with other anti-cancer treatments in adults with advanced or metastatic solid tumors that have a KRAS G12D mutation. This Phase III trial aims to assess the safety, how the drug moves through the body, and its initial effects in this patient group. The study is open-label and conducted at multiple centers with dose escalation and expansion phases. Participants receive GDC-7035 either as a single agent or combined with other anti-cancer therapies. The study follows a dose-escalation approach where doses are increased to find safe and effective levels. Both treatment arms involve protocol-defined dosing of GDC-7035, given sequentially. The trial includes a dose expansion phase to further evaluate the drugs effects at selected doses. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities using standardized criteria over four years. Blood and plasma samples will be collected at specific times to analyze drug concentrations, including comparisons of dosing with or without food. Researchers will measure tumor response rates, duration of response, and progression-free survival. The total study period extends up to the primary completion date in May 2028, with ongoing safety and activity assessments.

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan I-DXd in adults with various recurrent or metastatic solid tumors. These tumor types include endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 IHC 0 breast cancer, cutaneous melanoma, and neuroendocrine carcinoma. The study includes multiple phases to assess treatment effects and safety in these diverse groups. Participants receive I-DXd via intravenous infusion, typically dosed at 12 milligrams per kilogram, except in hepatocellular carcinoma where the dose is determined separately. The study is divided into three parts Stage 1, Stage 2, and an optional Stage 3 expansion for endometrial cancer, depending on safety and efficacy results. Each participant starts at Stage 1 and may continue to Stage 2 based on observed data. The hepatocellular carcinoma group includes a safety run-in phase to evaluate tolerability. Participants engage in regular assessments including imaging scans to measure tumor response and disease progression. Researchers monitor treatment-related side effects and collect blood samples to study how the drug behaves in the body over time. The studys main goal is to measure the objective response rate up to about 60 months after the first dose. Safety evaluations continue during treatment and for 47 days after the last dose. Participants may remain in the study for up to five years to track long-term outcomes and overall survival.

Researchers are investigating PF-06835375, a CXCR5 inhibitor, in adults with moderate to severe primary immune thrombocytopenia ITP, focusing on those with persistent or chronic forms lasting more than 3 months. This Phase 2, open-label, multicenter study aims to understand the safety and effects of PF-06835375 on platelet counts in these participants. Participants receive subcutaneous injections of PF-06835375 monthly. Those in cohort 1 are treated with a lower dose once a month for 3 months during a 12-week period. Participants in cohorts 2, 3, and 4 receive higher doses once a month for 4 months during a 16-week period. The treatment is designed to deplete certain immune cells to sustain platelet count improvements over time. During the study, researchers will monitor platelet counts, responses to treatment, circulating B cells, and circulating T follicular helper cells. Safety is also assessed by tracking adverse events related to the treatment from the start through the end of the study, which lasts up to 20 or 24 weeks depending on the cohort. Participants can expect regular monthly visits for injections and laboratory assessments throughout the treatment periods.