Torrette

Researchers are evaluating the safety, tolerability, and effectiveness of sonrotoclax alone and combined with other drugs in patients with relapsed or refractory multiple myeloma with a specific chromosomal translocation called t(11;14). This Phase 1b/2 study focuses on patients whose disease has returned or not responded to previous treatments, aiming to understand how well sonrotoclax works in these settings. The study assesses sonrotoclax given by mouth daily, either alone or combined with dexamethasone (given once weekly by mouth or intravenously), carfilzomib (weekly intravenous), daratumumab (weekly under the skin), or pomalidomide (daily by mouth). Different combinations are tested to find safe and effective dosing. The study includes dose-escalation and cohort-expansion phases to explore various treatment regimens. Participants will be closely monitored for side effects and treatment responses over time. Researchers will track dose-limiting toxicities during the first 28 days, adverse events up to 30 days after the last dose, and long-term responses over approximately 4 years. Assessments include measuring disease markers and overall response rates. Safety and efficacy data will guide future treatments for this patient population.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

Multiple myeloma is a cancer affecting plasma cells in the bone marrow. Researchers are evaluating how well Immune Globulin Infusion (human), 10% (IGI, 10%) can help prevent infections in adults with multiple myeloma receiving B-cell maturation antigen (BCMA) x CD3-directed bispecific antibody therapy. This phase 3 study aims to compare primary infection prevention using IGI, 10% versus secondary infection prevention in this patient group. Participants will be randomly assigned to one of two groups: the primary infection prevention group will receive IGI, 10% infusions for 12 months, while the secondary infection prevention group will receive IGI, 10% only if they develop a serious infection during the 12-month study period. The IGI, 10% is given intravenously. The study includes a screening period of up to 8 weeks, followed by treatment and monitoring. During the study, participants will attend 15 clinic visits if on a 4-week dosing schedule or 19 visits if on a 3-week dosing schedule, with total participation lasting up to 14 months. Researchers will monitor the time to first serious infection over 12 months. Participants will undergo evaluations to assess infection status and treatment safety throughout the study.

Researchers are evaluating the effectiveness, safety, and tolerability of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These participants experience repeated and/or serious infections due to low neutrophil levels. The study aims to show clinical benefit by increasing circulating neutrophils and reducing infection rates. Participants will continue their existing treatments, which may include granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement, prophylactic antibiotics, or observation without active treatment. They will be randomly assigned to receive either mavorixafor or a placebo, with both drugs given according to a set schedule. The study is double-blind and placebo-controlled, conducted across multiple centers. During the study, researchers will monitor participants for up to 52 weeks, focusing on the annual infection rate and the number of participants achieving a positive response in absolute neutrophil count. Participants will undergo regular assessments, including blood tests to measure neutrophil levels and evaluations for infections. The study includes safety monitoring and requires participants to maintain stable doses of their background therapies unless safety concerns arise.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

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.

Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor. As ASPEN-09-03 (MBC) is the only substudy open under ASPEN-09, the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria currently includes only MBC.

Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the third leading cause of cancer-related death. Most cases develop in a cirrhotic liver, where scarring makes treatment more difficult. This research aims to collect and analyze data from patients treated in everyday medical settings to understand how new combinations of immunotherapy drugs, like atezolizumab-bevacizumab and durvalumab-tremelimumab, work in real life. The study also seeks to find the best order of treatments and clinical markers that predict how well patients respond to these therapies. The study observes patients receiving frontline systemic treatments, including atezolizumab-bevacizumab or other immunotherapy combinations. It focuses on patients with advanced liver cancer who are not candidates for local treatments like surgery. While no specific interventions are assigned by the study, it collects data on treatment sequences and responses to these immunotherapies over time. Participants will be monitored from enrollment for up to three years to evaluate treatment safety and toxicity as first-line therapy. Researchers will gather clinical and laboratory data to identify markers predicting treatment outcomes and examine how factors like disease progression and second-line therapies impact survival. This long-term follow-up aims to provide real-world evidence to guide future treatment decisions for liver cancer patients.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.