Ciudad De Buenos Aires, Argentina
A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients
A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 [roginolisib hemi-fumarate]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients. This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).
Phase
1/2Span
145 weeksSponsor
iOncturaAntwerp
Recruiting
Testing and Evaluating a Psychoeducation Tool and Guidelines for Victims of Violence in Belgian Hospitals.
Phase
N/ASpan
32 weeksSponsor
University Hospital, GhentAntwerp
Recruiting
Healthy Volunteers
Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.
Inclusion and exclusion criteria Inclusion criteria Patients treated with CartiONE for knee cartilage lesion more than 6 months prior to inclusion in this study. The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion criterion Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation. Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,...) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan. There are two co-primary endpoints: Primary endpoint safety: Adverse events with particular focus on Treatment failure rate and on other AESIs Primary endpoint effectiveness: MOCART sub-score 1 "Volume fill of cartilage defect" Efficacy/Effectiveness: Key secondary endpoints: Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later. Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later. Other secondary endpoints: Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable Exploratory endpoint: "Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.
Phase
N/ASpan
96 weeksSponsor
Cartilage Repair Systems BVAntwerp
Recruiting
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Phase
N/ASpan
355 weeksSponsor
University Hospital, AntwerpAntwerp
Recruiting
Healthy Volunteers
Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis
Phase
N/ASpan
136 weeksSponsor
IRCCS Sacro Cuore Don Calabria di NegrarAntwerp
Recruiting
24-hour Movement Behaviors in Adults With Type 1 Diabetes
Phase
N/ASpan
84 weeksSponsor
University Hospital, GhentAntwerp
Recruiting
Study of JK06 in Patients with Unresectable Locally Advanced or Metastatic Cancer
This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of JK06 administered intravenously (IV) in patients with unresectable, locally advanced, or metastatic cancer. The study consists of a Dose Escalation phase to determine the MTD/recommended phase 2 dose (RP2D) of JK06, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK06 in tumor specific cohorts.
Phase
1/2Span
197 weeksSponsor
Salubris Biotherapeutics IncAntwerp
Recruiting
Transfer of Microorganisms Between Green Areas and Humans
Several hypotheses propose that the modern surge in immune disorders is related to diminished contact with nature. Specifically, the Biodiversity hypothesis emphasizes that contact with natural environments enriches the human microbiome and is necessary for promoting immune balance. This project aims to investigate whether visiting green areas can contribute to changes in human microbiome composition. Additionally, the investigators aim to explore the environmental, health and lifestyle factors that can influence these microbiome changes. Adults and/or children will be asked to visit a green space (such as an urban park) and perform specific activities (such as walking or pushing a stroller) for a defined time period. Before and after this visit, swabs of their skin and nose will be collected to analyze microbiome changes. In addition, questionnaires will be administered to the participants, with the goal to align microbiome changes with environmental, health, lifestyle and demographic factors.
Phase
N/ASpan
150 weeksSponsor
Universiteit AntwerpenAntwerp
Recruiting
Healthy Volunteers
Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
Phase
N/ASpan
66 weeksSponsor
University Hospital, AntwerpAntwerp
Recruiting
Healthy Volunteers
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be conducted in multiple phases: 1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404 2. To assess preliminary evidence of anti-tumor activity of CDR404 3. To characterise the pharmacokinetics of CDR404 4. To characterise the immunogenicity of CDR404 5. To assess translational biomarkers
Phase
1Span
188 weeksSponsor
CDR-Life AGAntwerp
Recruiting