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Researchers are evaluating a new combination of medicines, DSP107 and atezolizumab, compared with an existing treatment, fruquintinib, for people with advanced colorectal cancer that is microsatellite stable (MSS) or mismatch repair-proficient (pMMR). This Phase 2b, randomized, open-label study focuses on patients whose cancer has progressed on or who cannot tolerate standard therapies. The goal is to see if the new combination can improve outcomes while monitoring safety and how the body handles the treatments. Participants are randomly assigned to one of two groups. Group A receives DSP107 at 10 mg/kg intravenously on Days 1, 8, and 15 of each 28-day cycle, after an intravenous dose of atezolizumab 1680 mg on Day 1. Both infusions may have their durations shortened if well tolerated. Group B takes fruquintinib orally at 5 mg once daily on Days 1 to 21 each cycle, followed by 7 days off. The study includes a screening period up to 28 days, a treatment period of up to 24 cycles, and a safety follow-up lasting up to 90 days after the last dose. Participants will be closely monitored throughout the study with regular assessments to track cancer response, safety, and treatment effects. Researchers will measure median overall survival from the first day of treatment up to two years. The total time each participant stays in the study depends on factors like treatment tolerance and disease progression. This thorough process aims to gather important information about the benefits and risks of the new treatment combination compared to the standard oral therapy.

Researchers are evaluating the safety and early effectiveness of DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, multicenter, open-label trial includes participants with several types of cancer, including hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, and non-small cell lung cancer. The study focuses on targeted patients whose cancers have recurred, progressed, or are difficult to treat. The trial involves two treatment combinations delivered intravenously: DB-1311 with BNT327, and DB-1311 with DB-1305. Participants receive these investigational drug combinations under close observation. The study is divided into two parts: the first part evaluates dose-limiting toxicities within 21 days after the first dose, while the second part assesses treatment safety and response rates up to 72 months. This design allows researchers to monitor both short-term safety and long-term treatment effects. During the study, participants undergo regular assessments including monitoring for adverse events, tumor response evaluations using RECIST criteria, and organ function tests. The primary outcomes include the number of participants experiencing dose-limiting toxicities early in treatment and the objective response rate, which measures the proportion of participants showing significant tumor shrinkage. Safety monitoring continues throughout the study duration, with follow-up visits extending up to six years to observe long-term effects and participant health.

Researchers are evaluating DB-1419, a new drug, in a Phase 1/2a study for adults with advanced or metastatic solid tumors that have progressed despite standard treatments or for which no standard treatment exists. This first-in-human, multicenter, open-label trial aims to assess the safety, tolerability, how the drug moves through the body, and early signs of its effect against tumors in these patients. The study includes participants with measurable tumors and good heart function, who are expected to live at least three months and have a good performance status. Participants receive DB-1419 through intravenous injection. The study has two phases: Phase 1a focuses on finding the maximum tolerated dose and the recommended dose for later phases, lasting up to about 12 months. Phase 1b/2a evaluates the drug's safety and tumor response, continuing until disease progression, death, or other criteria. Some participants may provide tumor samples or undergo biopsy to measure specific biomarkers. Male and female participants of reproductive potential must follow pregnancy prevention guidelines during and after the study. During the study, participants are closely monitored with assessments including safety checks for adverse events up to 90 days after the last dose, heart function tests, and tumor evaluations based on established criteria. Researchers track serious side effects, drug tolerability, and tumor responses over time. Participants follow a schedule of visits and tests to ensure safety and collect data on the drug's effects, with the total study duration depending on the phase and individual response.