Callao

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and neutralization of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—administered intravenously in adults without HIV. This is a randomized, double-blind, controlled phase 2 clinical trial involving approximately 200 adult participants aged 18 to 65 years. The study aims to understand how these antibody combinations behave in the body and their safety profile over an 18-month participation period. Participants will receive intravenous infusions of the antibodies at different dosages: VRC07-523LS at 400 mg or 3200 mg, PGT121.414.LS at 400 mg or 1600 mg, and PGDM1400LS at 400 mg or 1600 mg. The study includes controlled administration of these biological treatments to assess their effects at varying dose levels. During the study, participants will undergo multiple assessments including monitoring for local and systemic adverse events at specific days (1, 4, 7, 169, and 173), and monitoring for unsolicited and serious adverse events throughout 48 weeks. Laboratory tests will evaluate changes in liver enzymes (ALT, AST, alkaline phosphatase), kidney function (creatinine), and complete blood count at baseline and several points up to day 337. Researchers will also track any early discontinuations and overall tolerability throughout the study duration.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of KarXT in men and women aged 55 to 90 years who have mild to severe Alzheimer's Disease with moderate to severe psychosis related to the condition. The main goal is to compare KarXT against a placebo by measuring changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician (NPI-C) score. Participants will receive different doses of KarXT ranging from 20/2 mg to 66.7/6.67 mg daily or placebo capsules. The study is designed to compare the effects of KarXT with placebo in a parallel group format, maintaining the double-blind setup to ensure unbiased results. During the study, participants will be assessed at the start and end of treatment (up to 14 weeks) to evaluate changes in psychotic symptoms. They will undergo clinical scales such as the NPI-C and the Clinical Global Impression-Severity (CGI-S) scale. The study also requires imaging scans like MRI or CT to rule out other brain diseases. A study partner who has regular contact with the participant will be involved to support adherence and observation. Safety and efficacy will be monitored throughout the treatment period.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.

The trial investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's Disease. This Phase 3 global, multicenter, open-label extension study lasts 52 weeks and enrolls participants who have completed earlier related studies (CN012-0026, CN012-0027, or CN012-0056). The purpose is to monitor how well patients tolerate KarXT over an extended period and to collect safety data. Participants receive KarXT in varying doses taken three times daily, ranging from 20/2 mg up to 66.7/6.67 mg per dose, corresponding to total daily doses between 60/6 mg and 200/20 mg. This treatment is provided throughout the 52-week open-label extension. The study includes only those who completed the previous related studies and continues to assess their response to KarXT over this longer timeframe. During the study, participants are closely monitored for treatment-emergent adverse events from the first dose through 14 days after the final dose, which may be up to 54 weeks. Regular assessments ensure safety and tolerability, and caregivers are involved to support participants. The study also evaluates participants' ability to continue living in their current setting and requires consent from the participant or their legal representative. Overall, the study tracks long-term safety outcomes in this specific patient group.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.