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Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating a new combination of medicines, DSP107 and atezolizumab, compared with an existing treatment, fruquintinib, for patients with advanced microsatellite stable colorectal cancer. This Phase 2b, randomized, open-label study focuses on individuals whose cancer has progressed or who cannot tolerate standard therapies. The study aims to assess whether the new combination improves treatment outcomes and safety compared to the current treatment options. Participants are randomly assigned to one of two groups. One group receives DSP107 intravenously on Days 1, 8, and 15 of each 28-day cycle with atezolizumab given intravenously on Day 1. The other group takes fruquintinib orally once daily on Days 1 to 21 of each 28-day cycle. The study includes a screening period of up to 28 days, a treatment period lasting up to 24 cycles, a safety follow-up period of up to 90 days after the last dose, and a long-term follow-up lasting up to 5 years from randomization. During the study, participants will have medical evaluations including monitoring of cancer response, safety assessments, and tests such as ECG and blood pressure measurements. Quality of life and immune response to treatment will also be tracked. Participants maintain dosing diaries if assigned to the oral treatment group. The primary outcome is overall survival, with ongoing safety and health status follow-up conducted for several years after treatment. Total study participation duration varies based on treatment tolerability and disease progression.

Researchers are evaluating the safety and preliminary effectiveness of DB-1311 combined with BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, open-label, multicenter trial includes participants with various cancers such as hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic ductal carcinoma, breast cancer, colorectal cancer, and metastatic castration-resistant prostate cancer. The trial involves escalating doses of the drug combinations DB-1311BNT324 with either BNT327 or DB-1305BNT325. These treatments are given intravenously to define recommended phase 2 doses in different patient groups. Participants are assigned to one of several study arms based on their cancer type and dose level, with treatment continuing as per protocol. The study aims to establish safe dosing and observe treatment responses over time. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events up to 72 months. The study will measure tumor response using RECIST 1.1 criteria and evaluate overall survival, progression-free survival, and other outcomes. Blood samples will be collected to study drug concentrations and immune responses. The trial includes follow-up visits to monitor safety and effectiveness throughout the study duration.

Researchers are conducting a Phase 12a clinical trial to evaluate DB-1419, a drug given by intravenous injection, for people with advanced or metastatic solid tumors that have relapsed, progressed, or have no standard treatment options. This open-label, multicenter study aims to assess the safety, tolerability, how the drug is processed in the body, and early signs of antitumor activity in participants. The trial is sponsored by DualityBio Inc. and includes adults aged 18 and older with measurable tumors or bone-only disease in some cases. Participants receive DB-1419 at various dose levels ranging from Dose Level 1 up to Dose Level 9. The study is non-randomized and includes dose escalation and dose expansion phases to determine the maximum tolerated dose and recommended dose for further study. The drug is administered by vein injection, and dosing cycles last either 14 or 21 days, with up to 8 cycles monitored for pharmacokinetics and immune response markers. During the study, participants undergo tumor assessments using RECIST v1.1 criteria to measure response, as well as monitoring for adverse events and serious adverse events for up to 90 days after the last dose or before new cancer treatment begins. Additional tests include cardiac function evaluation, blood tests for drug levels and antibodies, and physical exams. The study tracks progression-free survival, overall survival, and other safety and efficacy outcomes for approximately 12 months. Participants must provide consent and comply with study procedures throughout this period.