Maumee

Researchers are evaluating a new treatment approach for people with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after initial therapy with certain chemotherapy combinations. The study focuses on assessing the safety, tolerability, and overall survival when adding an experimental therapy called E-EDV-D682GC to standard chemotherapy drugs gemcitabine and nab-paclitaxel. This trial is a randomized, blinded Phase IIIa study designed to compare this combination against gemcitabine and nab-paclitaxel alone. The experimental treatment includes two investigational products E-EDV-D682, which packages a chemotherapy agent targeted to cancer cells expressing EGFR, and EDV-GC, which aims to boost the bodys immune response. Participants receive these drugs alongside gemcitabine and nab-paclitaxel. The trial has two parts an initial safety phase with at least six participants receiving the experimental combination to check for side effects, followed by a randomized phase where participants are assigned either to the experimental combination or to standard chemotherapy with placebo. Treatment cycles involve bi-weekly then weekly visits, with tumor assessments every 8 weeks to monitor response. Participants will be involved for about six months, including screening, treatment, and follow-up. They will undergo regular clinical visits, imaging scans to measure tumor burden, and safety assessments throughout the study and for up to 30 days after treatment ends. Researchers will monitor adverse events and overall survival, as well as measure disease progression and response using established imaging criteria. The study also includes a safety follow-up period to closely track participants health after treatment.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

This research aims to gather detailed molecular and clinical data from patients with hematologic cancers like Acute Myeloid Leukemia AML and Follicular Lymphoma FL. It is an observational study designed to explore how biomarkers relate to real-world outcomes in these conditions by following patients over time. The study is conducted by Tempus AI and involves multiple patient groups with different disease stages and risks. Participants are grouped mainly into newly diagnosed AML patients and various subgroups of Follicular Lymphoma patients categorized by disease status and treatment plans. The study involves collecting blood samples and leftover tissue or bone marrow during their routine medical care and monitoring without any investigational treatments or interventions. These samples will be analyzed to understand disease progression and response. During the study, participants undergo serial blood draws and provide tissue or bone marrow samples as part of their normal care. Researchers will examine molecular markers and link these findings to clinical outcomes over five years. The study does not involve any treatments and focuses entirely on observation and data collection. Participation may last up to several years, with ongoing monitoring of health and disease status.

Researchers are evaluating NRM-823, a bispecific T-Cell Engager drug, in adults with locally advanced or metastatic solid tumors that are refractory to treatment. The study focuses on cancers including non-small cell lung cancer, triple negative breast cancer, head and neck squamous cell carcinoma, esophageal and gastric adenocarcinomas, cervical, endometrial, and ovarian cancers. The trial aims to assess the safety and tolerability of NRM-823 alone and in combination with an immune checkpoint inhibitor. The study is divided into three parts. Part A evaluates the safety and tolerability of NRM-823 alone to identify a recommended dose. Part B further assesses safety and tolerability of that dose in a larger group of participants. Part C investigates the safety and tolerability of NRM-823 combined with a checkpoint inhibitor. Treatments are administered according to protocol requirements throughout these phases. Participants will be monitored from enrollment until 30 days after their last dose for treatment-emergent adverse events and dose-limiting toxicities. The study includes assessments of liver, kidney, lung, heart, and blood function to ensure safety. Participants will be followed closely to evaluate how their bodies tolerate the treatment and to gather information on side effects during and after the treatment period.

Researchers are studying TRI-611, an oral ALK molecular glue degrader, in adults with ALK-positive non-small cell lung cancer NSCLC. This Phase 12 trial aims to determine the safety, tolerability, and recommended dose of TRI-611 while also evaluating its antitumor activity. The study is sponsored by TRIANA Biomedicines, Inc. and focuses on participants who have varying prior treatments with ALK tyrosine kinase inhibitors TKIs. The trial has two parts Part 1 involves dose escalation to find the maximum tolerated dose and recommended Phase 2 dose through backfill cohorts. Part 2 includes three cohorts based on participants previous ALK TKI treatments, exploring the antitumor activity of TRI-611. Participants will take TRI-611 continuously while their disease does not progress. They will visit the clinic about seven times during the first three months and then once at the start of each 28-day cycle thereafter. Participants will keep a diary to record each dose of the study medication. Safety and response will be monitored through assessments such as adverse events within 28 days of the first dose and objective response rates approximately 16 weeks after dosing. The study also measures tumor response depth, duration of response, progression-free survival, and overall survival for up to five years after dosing. This includes special assessments for central nervous system involvement and tumor protein levels in consenting participants.

Researchers are evaluating pocenbrodib alone and in combination with darolutamide for treating metastatic castration-resistant prostate cancer mCRPC in patients who have progressed after prior therapies including anti-androgen treatments. This Phase 1b2a open-label study aims to confirm safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor effects of these treatments. It includes dose escalation, optimization, and dose expansion phases to find appropriate dosing levels and assess treatment effects in patients who have also received lutetium-Lu-177-vipivotide-tetraxetan PLUVICTO prior to taxane-based therapy. The study has two main phases Phase 1b involves dose escalation with three arms exploring different dosing schedules of pocenbrodib alone or combined with darolutamide to find the maximum tolerated dose and recommended Phase 2 doses. Phase 2a expands the study with two cohorts receiving different recommended doses of pocenbrodib combined with darolutamide. Treatments are given orally with varying dosing schedules including daily and twice-daily regimens, and safety is closely monitored throughout. Participants undergo regular assessments including safety evaluations, pharmacokinetic sampling during treatment cycles each 28 days, and tumor response evaluations. The primary outcomes focus on safety, tolerability, and efficacy measures such as radiographic progression-free survival and prostate-specific antigen changes. The study lasts through the treatment duration, estimated to be around six months for Phase 2a, with ongoing safety monitoring and data collection to understand drug behavior and patient response.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

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.