Saint Herblain

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are evaluating the safety, efficacy, and optimal dosing of a combination of two investigational treatments, BNT323 trastuzumab pamirtecan and BNT327 pumitamig, in people with advanced breast cancer. This includes those with hormone receptor-positive or -negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study is a Phase III multi-site, open-label trial with a focus on advanced breast cancer treatment options. The study has two parts. Part 1 involves dose escalation of BNT323 combined with BNT327 to determine the recommended Phase 2 dose using six different dose levels. Part 2, which begins after Part 1 completion, includes dose optimization and exploratory cohorts. Cohort 1 in Part 2 uses randomization into four treatment arms, including combination therapy at different doses and monotherapies of either BNT323 or BNT327. Other cohorts receive the recommended dose without randomization. Participants will undergo assessments including tumor scans and cardiac function tests, with monitoring for side effects and tumor response up to 36 months. Researchers will track dose-limiting toxicities and treatment-emergent adverse events during early treatment cycles and monitor objective response rates and disease control over time. Safety and efficacy data will be collected through scheduled visits and tumor assessments during and after treatment to evaluate the study drugs effects and tolerability.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating the experimental antibody COM701 to see if it can delay the progression of relapsed platinum sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The trial aims to find out if COM701, given as maintenance treatment, can slow disease progression, delay the need for new anti-cancer treatments, and to understand its safety profile in participants who have had prior platinum-containing therapies. This trial is a randomized, double-blind, placebo-controlled study where participants have a 67% chance to receive COM701 and a 33% chance to receive a placebo. The treatment is given through intravenous infusion once every three weeks. The study includes multiple sub-studies, with initial focus on COM701 alone and later evaluation of COM701 combined with other anti-cancer drugs as maintenance therapy. Participants will visit the clinic every three weeks for treatment infusion and undergo various health checks including physical exams, vital signs, ECG, blood and urine tests, and pregnancy tests if applicable. Disease response is monitored through tumor imaging by CT or MRI scans and analysis of tumor tissue samples. The main outcome is progression-free survival over up to two years, with safety monitored during and up to 90 days after treatment. The study duration and follow-up depend on individual participant progress.

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.