Dorado

Researchers are investigating the use of ASP2138, combined with chemotherapy and pembrolizumab, for adults with advanced gastric or gastroesophageal junction GEJ cancer that is HER2-negative and CLDN18.2-positive. This Phase 3 trial focuses on people whose cancer has spread nearby or to other parts of the body and cannot be removed by surgery. The study aims to find out if adding ASP2138 to standard treatments helps control the cancer and improves survival compared to placebo. Participants will be randomly assigned to one of two groups one group will receive ASP2138 by subcutaneous injection plus chemotherapy and pembrolizumab, while the other group will receive placebo injections with chemotherapy, with or without pembrolizumab. Treatments are given in 42-day cycles with specific dosing schedules depending on the chemotherapy regimen used. Participants will continue treatment until their cancer worsens, medical issues arise, or study rules require stopping. Throughout the study, participants will have regular safety checks and tumor scans to monitor disease status. Researchers will measure how long participants live without their cancer progressing and overall survival up to 54 months. Other assessments include response rates, adverse events, quality of life questionnaires, lab tests, and immune response markers. The study includes ongoing monitoring to gather comprehensive information on treatment effects and safety.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Crohns Disease CD is a digestive condition causing symptoms like chronic diarrhea, abdominal pain, weight loss, and fever. This research evaluates the pharmacokinetics, safety, and effectiveness of risankizumab in children aged 2 to under 18 years with moderately to severely active CD who have not responded well or cannot tolerate other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is now being studied for pediatric CD. The study includes three groups based on age, enrolling children from 2 to less than 18 years old. It has three parts an open-label 12-week induction phase where participants receive intravenous risankizumab based on their weight, a 52-week double-blind maintenance phase with subcutaneous risankizumab at one of two doses, and a 208-week open-label extension phase where treatment continues based on earlier responses. Participants who complete each phase may continue to the next, with dosing adjusted by age group. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor disease activity, side effects, and drug levels. Researchers will measure outcomes such as clinical remission and endoscopic response at 12 and 64 weeks, along with drug concentration in the blood. The total follow-up after treatment lasts about 140 days, with long-term monitoring during the extension phase.

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.