Maroochydore

Researchers are evaluating the safety and effects of VIB305 in adults with unresectable, advanced malignant solid tumors who have not responded to standard treatments, cannot receive them, or have declined existing therapies. This open-label, single-arm clinical trial includes a dose-escalation phase (Phase I) to assess safety, tolerability, and to find the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), followed by a dose-expansion phase (Phase II) to further evaluate safety, pharmacokinetics, preliminary anti-tumor activity, and immune response in specific tumor types. Participants receive VIB305 through intravenous infusion once a week in treatment cycles lasting three weeks. Phase I focuses on determining dose limiting toxicities (DLTs) during the first 21-day cycle. Phase II enrolls additional patient groups based on Phase I results to continue evaluating safety and drug behavior in the body. Throughout the study, participants are closely monitored for adverse events from consent signing until 30 days after their last dose. Researchers assess safety outcomes, including DLTs by the end of Cycle 1, and observe pharmacokinetics and preliminary efficacy during the expansion phase. The study involves regular evaluations to track health status and treatment effects over the course of participation.

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in adults with locally advanced unresectable or metastatic solid tumors. This Phase 1/2, open-label, multicenter study aims to determine the safety, tolerability, dose-limiting toxicities, maximum tolerated dose, maximum administered dose, and recommended Phase 2 dose of IBI354. The study also explores and confirms the drug's efficacy, safety, and tolerability in this patient population. Participants receive sequential doses of IBI354 during the study. The trial includes a Phase 1a dose-escalation period to establish dose limits and Phase 1b/2 periods enrolling subjects with specific solid tumors expressing HER2 to evaluate treatment effects. Dosing schedules and administration details are guided by safety and tolerability findings. The study drug is administered as an injection. Throughout the study, researchers monitor participants for serious adverse events and treatment-emergent side effects up to 30 days after the last dose. Dose-limiting toxicities are specifically assessed during the first 21 days of treatment in Phase 1a. Participants undergo evaluations including echocardiography to check heart function before drug administration. Safety, response, and tolerability are closely followed to understand the treatment impact and support future dosing decisions.

Researchers are evaluating the safety and effectiveness of a topical treatment called recombinant human Proteoglycan 4 (rhPRG4) for people with Sjögren's related Dry Eye Disease. This Phase II, randomized, double-masked, controlled study is conducted across multiple centers in Australia. The goal is to compare rhPRG4 to a vehicle control to see if it improves dry eye symptoms associated with Sjögren's syndrome. Participants will be randomly assigned to receive either rhPRG4 at a concentration of 450 µg/ml or a PBS-based vehicle control. The treatment is applied topically to the eyes, and the study carefully monitors how patients respond to the therapy over a 28-day period. The main focus is on the resolution of corneal staining, which is a marker of eye surface damage. Throughout the study, participants will attend scheduled clinic visits where researchers will assess their eye condition using fluorescein staining and symptom questionnaires. They will track treatment adherence and monitor safety and side effects. The primary outcome is the frequency of patients who achieve complete healing of corneal staining by Day 28. Participation lasts for the duration of the 28-day treatment period with ongoing evaluations to measure the therapy's impact.

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 different treatment strategies for patients hospitalized with Gram-negative bloodstream infections (GN BSIs) through the BALANCE+ trial. This adaptive platform trial uses an open-label, pragmatic design embedded in routine care to address important questions in managing GN BSIs, including antibiotic treatment duration, antibiotic de-escalation, oral antibiotic options, central line management, specific pathogen treatment, and follow-up blood cultures. The study builds on previous research and aims to improve patient outcomes and reduce antimicrobial resistance, a growing global health concern. The trial includes multiple treatment comparisons, such as de-escalation versus no de-escalation of antibiotics, oral beta-lactams versus non-beta-lactams, central vascular catheter retention versus replacement, cephalosporin versus carbapenem for low-risk AmpC organisms, and routine follow-up blood cultures versus no routine follow-up. Treatments are tailored based on blood culture results and clinical decisions, with specific protocols for antibiotic switching and catheter management. The trial uses Bayesian methods with interim analyses after every 1000 patients initially, then every 200 patients, and stops domains based on predefined criteria or sample sizes. Participants are patients admitted to hospitals with confirmed Gram-negative bacteremia who meet eligibility criteria for each domain. Assessments include monitoring for death, reinfection, readmission, and new antimicrobial resistance over 90 days, measured by the Desirability of Outcome Ranking (DOOR) scale. The trial incorporates detailed inclusion and exclusion criteria and collects data through routine clinical care, ensuring ongoing evaluation of treatment effectiveness and safety throughout the study period.

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.

Researchers are evaluating the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analog, as an additional treatment for adults with Major Depressive Disorder (MDD). This Phase III, multi-center, double-blind, randomized controlled study compares two active doses of CYB003 against a placebo in patients experiencing moderate to severe depression who have not adequately responded to stable antidepressant treatment. Participants will receive either one of two doses of CYB003 or a placebo, along with manualized psychological support provided by a facilitator. The study includes a screening period, a dosing period, and follow-up assessments. The psychological support sessions are standardized to assist participants during the trial. During the study, participants will be assessed using the Montgomery-Asberg Depression Scale (MADRS) at multiple time points including screening, baseline, and several days during treatment up to the trial's end at Day 84. Researchers will monitor symptoms of depression, safety, and tolerability throughout the trial. Participants will also undergo various evaluations to ensure adherence and safety during the study period, which spans approximately 12 weeks from screening through the final assessment.

Researchers are evaluating the safety, tolerability, early clinical effects, pharmacokinetics, and pharmacodynamics of azenosertib (also known as ZN-c3) combined with chemotherapy or bevacizumab in women with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label, multicenter study includes patients with platinum-resistant or advanced disease and explores two parts: combination with chemotherapy and combination with bevacizumab as maintenance therapy after platinum-based chemotherapy. The study has two parts. Part 1, which is completed, tested azenosertib with chemotherapy drugs including pegylated liposomal doxorubicin, carboplatin, paclitaxel, or gemcitabine in patients with platinum-resistant cancer. Part 2 is ongoing and involves dose escalation and expansion phases to assess azenosertib combined with bevacizumab as first- or second-line maintenance treatment. Dose escalation identifies the recommended dose, while dose expansion evaluates this dose in patients who responded to prior platinum therapy and progressed on a PARP inhibitor. Participants will be monitored for safety and tolerability throughout the study, which can last about one year. Researchers will measure maximum tolerated dose, pharmacokinetics, and clinical responses, including disease control. Evaluations include medical assessments, laboratory tests, and monitoring of adverse effects. The study aims to find safe dosing and gather preliminary activity data to support further research.

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.