Tuzla Grad

Researchers are evaluating the safety, tolerability, early clinical effects, pharmacokinetics, and pharmacodynamics of azenosertib (also known as ZN-c3) combined with chemotherapy or bevacizumab in women with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label, multicenter study includes patients with platinum-resistant or advanced disease and explores two parts: combination with chemotherapy and combination with bevacizumab as maintenance therapy after platinum-based chemotherapy. The study has two parts. Part 1, which is completed, tested azenosertib with chemotherapy drugs including pegylated liposomal doxorubicin, carboplatin, paclitaxel, or gemcitabine in patients with platinum-resistant cancer. Part 2 is ongoing and involves dose escalation and expansion phases to assess azenosertib combined with bevacizumab as first- or second-line maintenance treatment. Dose escalation identifies the recommended dose, while dose expansion evaluates this dose in patients who responded to prior platinum therapy and progressed on a PARP inhibitor. Participants will be monitored for safety and tolerability throughout the study, which can last about one year. Researchers will measure maximum tolerated dose, pharmacokinetics, and clinical responses, including disease control. Evaluations include medical assessments, laboratory tests, and monitoring of adverse effects. The study aims to find safe dosing and gather preliminary activity data to support further research.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

The trial investigates the safety and effectiveness of a medication called OCTAPLEX, a four-factor prothrombin complex concentrate, in patients experiencing acute major bleeding while on direct oral anticoagulant (DOAC) therapy with a factor Xa inhibitor. This phase 3, multicenter, prospective, randomized, double-blinded study compares two doses of OCTAPLEX, low-dose and high-dose, to assess hemostatic efficacy in this patient group. Participants will be randomly assigned in a 1:1 ratio to receive either the low-dose or high-dose OCTAPLEX. The study focuses on patients who have acute major bleeding related to their use of oral factor Xa inhibitors. Treatment administration and the comparison of dosing strategies are designed to evaluate how well OCTAPLEX controls bleeding in these patients. During the study, researchers monitor the effectiveness of the treatment by measuring hemostatic efficacy within 24 hours after starting management. Patients are closely observed for safety and treatment response. The duration of participation involves initial treatment and monitoring of bleeding control, with assessments based on clinical signs and laboratory tests related to bleeding and clotting function.