Al Ain

Researchers are evaluating the safety, side effects, and effectiveness of EP0031, a potent next-generation selective RET inhibitor, in adult patients with advanced RET-altered malignancies, including non-small cell lung cancer (NSCLC). This modular, interventional Phase I/II study aims to find the optimal dose of EP0031, especially for patients who have progressed on first-generation selective RET inhibitors (SRIs) and currently have no approved alternative therapies. The study builds on the completion of Phase I, where dose escalation and optimization led to the selection of a recommended Phase II dose (RP2D). Participants receive EP0031 treatment during the study. Phase I involved dose escalation and optimization to determine safety and tolerability. Phase II focuses on evaluating the efficacy of EP0031 at the selected dose. The treatment period includes monitoring for dose-limiting toxicities (DLTs) during the first 28 days and measuring overall response rate (ORR) over 12 months using established response criteria (RECIST v1.1). Throughout the study, participants will undergo regular assessments to monitor safety, side effects, and treatment response. These include clinical evaluations, laboratory tests, and imaging studies. Researchers will track adverse effects, pharmacokinetics, and tumor response over time. The study requires participants to be able to consent and comply with all procedures, with a minimum life expectancy of over 3 months. Continuous monitoring aims to ensure participant safety and to gather data on EP0031's potential benefits over a 12-month period.

This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating whether transferring a single euploid embryo in a natural cycle without routine luteal phase support (LPS) is as effective as transfers with LPS. The study focuses on women aged 18 to 40 years with regular ovulatory cycles who have at least one tested euploid embryo. If the study shows no difference in live birth rates, it could simplify treatment and improve patient comfort. Participants will undergo monitoring with intermittent transvaginal ultrasounds to track follicle growth and serial blood tests measuring luteinizing hormone (LH), estradiol (E2), and progesterone (P4) to confirm ovulation. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer (ET), with dosing adjusted up to 300 mg daily until pregnancy testing. The study compares outcomes between those who receive vaginal progesterone and those who do not. Throughout the study, participants will have blood tests to measure hormone levels on the day of ET and several days afterward. Pregnancy confirmation is done by measuring serum hCG 10 days post-ET. Key outcomes assessed include implantation rate and clinical pregnancy rate at 2 months, as well as live birth rate after 41 weeks. Hormone levels will be closely monitored to understand their relationship to pregnancy success.

Researchers are exploring whether a lower ovarian reserve is linked to having more early miscarriages in women who have experienced previous pregnancies. The study focuses on populations with specific reproductive histories, such as recurrent pregnancy loss, no prior pregnancies, and ectopic pregnancy, to understand how a low ovarian reserve affects fertility outcomes. This knowledge aims to help improve clinical decisions and fertility treatments for those affected. Participants will undergo diagnostic tests during their first consultation, including a transvaginal ultrasound to count antral follicles and a blood test to measure Anti-Müllerian Hormone (AMH) levels. These tests help assess ovarian reserve and provide insight into embryo quality through genetic testing for aneuploidies in some cases. The study observes the impact of low ovarian reserve on fertility without introducing new treatments. Throughout the study, researchers will collect data from participants at fertility clinics in Abu Dhabi, Al Ain, and Dubai. They will monitor ovarian reserve markers such as AMH and antral follicle count on the day of the initial visit. The study aims to improve understanding of fertility challenges, support better treatment strategies, and help participants achieve their goal of becoming parents while reducing anxiety related to infertility.

Researchers are evaluating the effectiveness and safety of plozasiran in about 288 adults who have severe hypertriglyceridemia (high levels of triglycerides in the blood) and a history of at least two acute pancreatitis events, with at least one occurring within the last year before screening. This Phase 3 study compares plozasiran to a placebo in a double-blind manner to better understand its impact on reducing pancreatitis risk in this population. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo through subcutaneous injections every three months. They will be advised to continue a low-fat diet and maintain their usual lipid- and triglyceride-lowering medications throughout the study. After completing the double-blind treatment period or experiencing an acute pancreatitis event, participants will enter a 12-month open-label phase where all receive plozasiran 25 mg injections every three months. During the study, participants will be monitored for the time until their first confirmed acute pancreatitis event starting more than 10 days after the first dose, with follow-up lasting up to approximately 50 months. Researchers will assess treatment effects, safety, adherence to diet and medications, and overall participant health. The study includes regular evaluations to ensure participant safety and collect data on the treatment's impact on severe hypertriglyceridemia and pancreatitis risk.