Chenor

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating whether the medicine spesolimab can help adults with ulcerative pyoderma gangrenosum PG, a skin condition characterized by painful ulcers. The main goal is to see if spesolimab can lead to healing and closure of these ulcers. This Phase 3 study includes adults with at least one ulcer measuring between 5 cm and 80 cm and is sponsored by LEO Pharma. The study has two parts. In Part 1, participants are randomly assigned to receive either spesolimab or a placebo infusion every 4 weeks, with a 2 in 3 chance of receiving spesolimab. Alongside this, all participants take corticosteroid medicine by mouth for the first 8 weeks. In Part 2, participants are grouped again, where those without open ulcers have an equal chance of receiving spesolimab or placebo, while those with open ulcers receive spesolimab. Treatment infusions continue every 4 weeks throughout the study. Participants will be involved in the study for about 1.5 years, attending around 20 visits to the study site. During visits, doctors will examine their skin for signs of PG, monitor their overall health, and check for any side effects. The study team will compare results between groups, focusing especially on the complete closure of ulcers up to 28 weeks, among other measures of skin healing and pain reduction.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab for adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma. This study focuses on the dual targeting of EGFR and TGF-beta, which contribute to tumor growth and spread. It includes both phase 2 and phase 3 parts to identify the best dose and to compare treatment outcomes. In phase 2, participants are randomized into three groups receiving either higher or lower doses of ficerafusp alfa plus pembrolizumab, or placebo plus pembrolizumab. In phase 3, participants receive the selected optimal biologic dose of ficerafusp alfa with pembrolizumab or placebo with pembrolizumab in a 21 ratio. Treatments are given weekly or every three weeks depending on the drug, with careful monitoring throughout the study. Participants will undergo tumor biopsies or provide archival tissue, and receive regular assessments including imaging scans and lab tests to measure tumor response and safety. Researchers will track side effects, response rates, survival, and quality of life using standardized criteria over approximately 1 to 3 years. Safety monitoring continues up to 90 days after treatment ends. The total study duration extends through long-term follow-up to evaluate overall outcomes.