Al Ain

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating EP0031 Lunbotinib, a next-generation selective RET inhibitor, in adults with advanced RET-altered non-small cell lung cancer NSCLC. This Phase III study aims to find the optimal dose and assess the safety, side effects, and effectiveness of EP0031 alone and in combination with standard chemotherapy. The study addresses a critical need as no approved RET-targeted treatments exist for patients whose cancer progresses after first-generation selective RET inhibitors SRIs. Participants receive EP0031 capsules once daily at the recommended dose alongside platinum-based doublet chemotherapy on Day 1 of each 21-day cycle, for up to four cycles. Following this, participants continue EP0031 with pemetrexed maintenance until disease progression, unacceptable side effects, or withdrawal. The study includes two groups treatment-naive patients and a now-closed cohort previously treated with a first-generation SRI. The Phase 1 dose escalation has completed, and the study is currently in Phase 2. During the trial, participants undergo regular assessments including tumor measurements using RECIST v1.1 criteria, safety and tolerability monitoring, and pharmacokinetic tests to measure drug levels in the body. Key outcomes include evaluating dose-limiting toxicities within the first 21 days and measuring overall response rates over 12 months. The study continues until March 2028, with ongoing observation of effects and side effects throughout treatment.

Researchers are evaluating the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a chemotherapy payload, compared to treatment chosen by physicians including paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine for patients with first-line metastatic triple-negative breast cancer TNBC or low estrogen receptor ER-low, HER2-negative breast cancer who cannot receive anti-PDL1 or endocrine therapies. This study includes adults with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria. Participants are randomly assigned to receive iza-bren or one of the physicians choice chemotherapy regimens. The treatments are given at specified doses on scheduled days. The study includes two phases Phase 2 to determine the recommended dose of iza-bren and Phase 3 to compare progression-free survival and other outcomes. The study will last several years, with follow-up extending up to approximately 47 months after randomization. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and monitoring for adverse events. Quality of life questionnaires will also be completed. Researchers will track progression-free survival, overall survival, treatment-related side effects, tumor size changes, and patient-reported outcomes to evaluate the treatments. The total participation duration may extend up to several years depending on treatment response and follow-up requirements.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are studying real-world treatment patterns, patient characteristics, survival outcomes, and safety of Trastuzumab Deruxtecan T-DXd in women with hormone receptor-positive metastatic breast cancer mBC that is HER2-low or HER2-ultralow. This study focuses on patients previously treated with endocrine therapy and aims to provide data from Gulf Cooperation Council countries to improve treatment strategies and clinical guidelines for mBC in the region. This observational study monitors patients who have initiated T-DXd treatment as part of routine care, including those who started the drug up to 30 days before consenting to participate. It includes women aged 18 years or older with confirmed HR-positive, HER2-low or ultralow metastatic breast cancer who have not received chemotherapy in the metastatic setting. The study collects data over 18 months on treatment patterns, safety, and progression-free survival. Participants are observed while receiving their usual medical care with T-DXd, without additional intervention by the study team. Researchers collect information on patient characteristics, treatment details, safety events, and time to next treatment. The main outcome measured is real-world progression-free survival at 18 months, along with safety profiles and treatment patterns. The study is expected to last until March 2029, supporting improved outcomes through real-world evidence.

Researchers are evaluating whether transferring a single genetically normal embryo during a natural menstrual cycle without routine luteal phase support LPS is not worse than transferring with LPS. This study focuses on women with regular ovulatory cycles who have at least one genetically tested embryo available, aiming to simplify treatment and improve participant comfort if the outcomes are similar. Participants are randomly assigned to one of two groups. Both groups will have intermittent ultrasounds and blood tests measuring hormone levels to monitor ovulation. In the group without LPS, embryo transfer is scheduled five days after ovulation without additional progesterone support. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer and continuing until the pregnancy test, with support extended to seven weeks if pregnancy occurs. Throughout the study, participants will undergo multiple hormone measurements and ultrasounds to track follicular growth and hormone levels before and after embryo transfer. Pregnancy confirmation will occur via blood tests 10 days after transfer. The study will measure implantation rate, clinical pregnancy rate, live birth rate, and hormone levels at specific time points. Participant involvement includes frequent clinic visits for monitoring and blood draws over the course of the treatment cycle and early pregnancy period.

This research aims to explore whether there is a link between decreased ovarian reserve and a history of early miscarriage. By studying groups with specific reproductive histories, including recurrent pregnancy loss, no previous pregnancies G0, and ectopic pregnancy, investigators hope to better understand how low ovarian reserve LOR affects fertility outcomes. The goal is to provide information that can guide decisions about fertility treatments and interventions for those with LOR. Participants will undergo routine clinical assessments and testing of ovarian reserve, including blood tests for anti-Mllerian hormone AMH and transvaginal ultrasound for antral follicle count AFC. No additional interventions beyond standard care and typical stimulation protocols are involved. The study observes different participant groups based on AMH levels and pregnancy or miscarriage history. During the study, participants will have AMH and AFC tests performed on the day of their first consultation. Researchers will measure these factors to assess ovarian reserve and relate them to participants reproductive histories. This observational study collects data that may improve understanding of fertility challenges and help inform future treatment options. The study is expected to complete by the end of 2026.

Researchers are evaluating plozasiran in adults with severe hypertriglyceridemia SHTG who have experienced at least two prior acute pancreatitis AP events, with one event occurring within the last 12 months before screening. The study aims to assess the efficacy and safety of plozasiran compared to a placebo in reducing AP events and managing triglyceride levels. About 288 adult participants will be involved in this randomized, double-blind, phase 3 clinical trial. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months Q3M. They will be counseled to maintain a low-fat diet and continue their prescribed lipid and triglyceride-lowering medications throughout the study. After the double-blind treatment period or upon experiencing a confirmed AP event, participants will enter a 12-month open-label extension, receiving plozasiran 25 mg by subcutaneous injection every three months. During the study, participants will be regularly monitored for the time to first AP event, changes in fasting serum triglyceride levels, cardiovascular events, patient-reported productivity, and health status. Safety assessments will include tracking treatment-emergent adverse events. The study will last approximately up to 62 months, including the double-blind and open-label phases, with ongoing evaluations and follow-up visits to assess treatment effects and participant health.