Chenor

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating sacituzumab tirumotecan as a second-line treatment for female participants with recurrent or metastatic cervical cancer who have previously received platinum chemotherapy and anti-PD-1/PD-L1 therapy. This study has two phases: a safety run-in to assess the safety and efficacy of sacituzumab tirumotecan, followed by a Phase 3 portion comparing sacituzumab tirumotecan to treatment chosen by physicians. The study aims to determine if sacituzumab tirumotecan improves overall survival, especially in participants with high TROP2 expression. Participants will receive intravenous infusions of sacituzumab tirumotecan during the safety run-in phase. In the Phase 3 portion, participants are randomized to receive either sacituzumab tirumotecan or one of several physician-chosen treatments including pemetrexed, tisotumab vedotin, topotecan, vinorelbine, gemcitabine, or irinotecan, all given by IV infusion. This setup allows comparison of sacituzumab tirumotecan monotherapy against standard second-line therapies. Throughout the study, participants will undergo evaluations for tumor response, adverse events, and overall survival, with monitoring lasting up to approximately 51 months for the safety run-in and about 43 months for the Phase 3 portion. Researchers will use imaging and tumor tissue analysis to assess measurable disease and TROP2 expression. Safety and treatment tolerability will be closely observed, including tracking discontinuations due to adverse events.

Researchers are evaluating the medicine spesolimab to see if it helps adults with ulcerative pyoderma gangrenosum (PG), a skin condition that causes ulcers. This Phase 3 trial focuses on whether spesolimab can lead to complete closure of PG ulcers. Adults with at least one ulcer measuring between 5 cm² and 80 cm² are eligible to participate. The study is conducted in two parts, each with different randomization and treatment rules. Participants receive either spesolimab or a placebo through vein infusions every four weeks. In Part 1, participants are randomly assigned with a 2 in 3 chance to receive spesolimab while also taking corticosteroids by mouth for 8 weeks. In Part 2, those without open ulcers are again randomized to spesolimab or placebo, while those with open ulcers receive spesolimab. The study treatment is carefully controlled and blinded so neither participants nor doctors know who receives the medicine or placebo. Participants will visit the study site about 20 times over 1.5 years. At each visit, doctors check the skin ulcers and overall health, monitoring for any side effects. The main outcome measured is whether the target PG ulcer achieves complete closure by Week 26, confirmed at least 2 weeks later. This long-term monitoring helps researchers understand the safety and effectiveness of spesolimab for treating PG ulcers.

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.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.