Be Er Ya Akov

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

This trial investigates the safety, tolerability, and pharmacokinetics (PK) of OMN6 in adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by the Acinetobacter baumannii complex (ABC). It is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study designed to find safe and well-tolerated doses of OMN6 and to measure how the drug behaves in the body of affected patients. Participants receive one-day treatment with OMN6 given as three 3-hour intravenous infusions in either 50 mg, 100 mg, or 150 mg doses three times a day. This treatment is given alongside background antimicrobial therapy with meropenem and colistin, which is continued for 7 to 14 days. A matching placebo group receives the same infusion schedule and background therapy without OMN6. During the study, researchers monitor the safety of the single-day OMN6 treatment over 28 days and assess PK measures such as the peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 within one day. Patients are closely observed for side effects and treatment responses during this period to gather information on safety and drug behavior.

Researchers are evaluating the safety and effectiveness of EscharEx (EX-03 5% formulation), a gel made from a sterile lyophilized powder containing proteolytic enzymes, compared to a placebo gel without enzymes. The study focuses on the treatment of Venous Leg Ulcers (VLU), which are wounds on the legs caused by poor venous blood flow. This Phase 3 trial will involve at least 216 adults with VLUs that range in size from 2 to 25 square centimeters and have lasted between 4 weeks and 12 months. Participants will be randomly assigned to receive either EscharEx or the placebo in a double-blinded setup, meaning neither patients nor researchers know which treatment is given. The study lasts up to 29 weeks and includes several stages: a screening period with two visits one week apart; a daily treatment phase with up to eight daily applications over two weeks to remove necrotic tissue; a weekly wound management period lasting up to 12 weeks with up to 13 visits, plus up to two weeks for confirming wound closure; and finally, a 12-week monthly follow-up with three visits to monitor wound closure durability. Throughout the study, researchers will visually assess the removal of dead tissue after each treatment application and monitor the time it takes for the wound to fully close. Patients will undergo standardized wound care and regular clinical evaluations, including measurements of the wound area. Safety and wound healing progress will be carefully tracked during all visits, ensuring comprehensive monitoring of treatment effects and wound status over the entire study duration.

Researchers are evaluating the safety and preliminary effectiveness of SAR445877, given alone or with other anticancer treatments, in adults aged 18 and older who have advanced, hard-to-remove, or metastatic solid tumors. This Phase 1/2 study includes multiple groups and aims to find appropriate doses and understand how well the treatment works, including combinations with cetuximab, ADG126, or bevacizumab. The study involves about 542 participants, including those in a Japan-specific group, reflecting a wide range of advanced solid tumor types. The study has two main parts. Part 1 focuses on dose escalation to identify safe and effective doses of SAR445877 given either every two weeks or weekly, alone or combined with other therapies. Part 2 involves expanding and optimizing doses to assess safety and early effectiveness in various tumor types and treatment combinations. Participants receive SAR445877 and other drugs by infusion. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping treatment. Participants will undergo screening for up to 28 days before starting treatment, then receive ongoing therapy with regular monitoring. Assessments include scans and tests to measure tumor response, safety evaluations for side effects including dose-limiting toxicities, and follow-up visits after treatment ends. The study tracks outcomes during treatment cycles and for up to two years in the expansion phase, with safety follow-up lasting 30 days after the last dose. Overall, the participation duration varies depending on individual course and response.

This research investigates the long-term effects of mirikizumab in children and adolescents aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohn's disease. The study is designed as a Phase 3, multicenter, open-label extension trial aiming to assess the ongoing safety and efficacy of this treatment in pediatric participants. It includes those who have completed previous related studies and are expected to benefit from continued mirikizumab treatment. Participants will receive mirikizumab either by subcutaneous injection or intravenous infusion as part of this extended treatment. The study may last approximately 172 weeks and involve up to 44 visits over this period. There is also a possibility for participants to continue receiving treatment through a Continued Access Period after the main study. Throughout the study, participants will be regularly monitored with clinical assessments to determine remission status using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohn's Disease Activity Index for Crohn's disease at week 52. Safety and efficacy will be closely followed, including the evaluation of any adverse events or changes in disease activity, ensuring comprehensive long-term observation.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are evaluating the safety and effectiveness of fosmanogepix, given either intravenously or orally, for treating adults diagnosed with invasive mold infections. This Phase 3 study focuses on patients infected with molds such as Aspergillus species, Fusarium species, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant molds. The main goal is to compare the overall death rate at 42 days against a fixed threshold to assess treatment outcomes. Participants will be assigned to one of two groups: Cohort A includes patients receiving either the study drug fosmanogepix or the standard antifungal treatment based on institutional practice, while Cohort B includes patients receiving fosmanogepix as a salvage treatment after not responding to or not tolerating prior therapies. Fosmanogepix is administered through intravenous infusion or oral tablets. The study treatment period targets 84 days but can be extended up to 180 days depending on patient needs. Throughout the study, lasting up to approximately 8 months including follow-up, participants will undergo evaluations to monitor their response, safety, and overall health status. Researchers will track the all-cause mortality rate by Day 42 as the primary outcome. Safety and treatment effects will be assessed regularly during treatment and follow-up to ensure participant well-being and gather comprehensive data on fosmanogepix’s impact.

Researchers are evaluating the efficacy and safety of UGN-104, a new formulation of UGN-101 (known as JELMYTO), for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This Phase 3, single-arm, multicenter study focuses on patients with LG-UTUC in the upper urinary tract. The study aims to measure the complete response rate about 3 months after the first treatment instillation. Participants will receive UGN-104 once weekly for 6 weeks, totaling 6 doses. UGN-104 is a drug combining mitomycin with a sterile hydrogel that changes from liquid to gel when warmed, helping deliver the medication directly to the upper urinary tract. Patients who achieve a complete response with no detectable disease at the primary disease evaluation visit may enter a follow-up period, where they can receive monthly maintenance doses of UGN-104 for up to 11 months. Patients will be monitored every 3 months during follow-up for up to 12 months or until disease progression, recurrence, or death. Throughout the study, patients undergo evaluations including urine cytology, visual inspections with ureteroscopy, and biopsies if needed. Response determination is centrally reviewed using laboratory and histopathology assessments. Safety and disease status will be closely monitored during treatment and follow-up visits to assess treatment effect and patient well-being.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.