Gaia

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are investigating the pharmacokinetics (PK), tolerability, and safety of a single 10 mg dose of rupatadine and its active metabolites in adults with varying degrees of renal impairment compared to matched adults with normal kidney function. This open-label, non-randomized, parallel group study focuses on how kidney function affects the body's processing of rupatadine. The study includes participants with mild, moderate, and severe renal impairment as well as matched control participants based on gender, age, and body weight. Participants will undergo a screening period up to 28 days before dosing, followed by a baseline evaluation one day prior to treatment. On Day 1, all participants receive a single 10 mg rupatadine tablet after fasting overnight, and continue fasting for four hours post-dose. Those with renal impairment will have blood samples collected for PK analysis over 264 hours, while participants with normal renal function will have sampling over 144 hours. Safety and tolerability are closely monitored, with enrollment of participants with different levels of renal impairment staggered based on safety data. The study concludes with an End of Study visit on Day 12 for impaired participants and Day 8 for normal participants. Throughout the study, participants stay at the clinic from the day before dosing until 24 hours after dosing. They undergo multiple blood draws according to schedule, safety evaluations, and laboratory testing. Researchers measure plasma drug and metabolite concentrations and assess various PK parameters such as peak levels, clearance, and half-life. Safety monitoring continues through the End of Study visit. The entire study duration, including screening and follow-up, lasts up to approximately 40 days.