Maroochydore

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of VIB305, an intravenous drug, in adults with advanced solid tumors that cannot be removed by surgery and who have not responded to or cannot undergo standard treatments. This clinical trial is an open-label, non-randomized study with dose-escalation Phase I and dose-expansion Phase II phases to identify the maximum tolerated dose and recommended dose for further study. Participants receive VIB305 through intravenous infusion once a week, with each treatment cycle lasting three weeks. The study includes six different dose cohorts, with dosing and safety monitored closely during the dose-escalation phase to assess adverse events and dose-limiting toxicities. The dose-expansion phase will further evaluate the drugs safety, pharmacokinetics, immune response, and preliminary anti-tumor activity in selected tumor groups based on earlier results. Throughout the trial, participants will undergo regular assessments including adverse event monitoring, tumor measurements, blood sampling for pharmacokinetic and immunogenicity analysis, and evaluations of treatment response and disease progression. The primary outcomes focus on safety and determining the maximum tolerated dose after the first treatment cycle, while secondary outcomes include immune response, tumor control rates, and pharmacokinetic profiles. Monitoring continues up to 30 days after the last drug administration, with ongoing follow-up to assess treatment effects and participant health.

This trial is designed for adults diagnosed with metastatic pancreatic ductal adenocarcinoma PDAC who have not yet received systemic treatment for their advanced cancer and have a good performance status. The study evaluates pumitamig, an investigational drug, in combination with chemotherapy to assess its safety and effectiveness. This phase II trial plans to explore different chemotherapy regimens combined with pumitamig to understand their impact on the disease.

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in people with locally advanced unresectable or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, and dose-limiting toxicities to find the maximum tolerated or administered dose and the recommended Phase 2 dose of IBI354. The study also explores the drugs effectiveness and safety in this patient population. Participants receive sequential doses of IBI354 through a single-arm treatment plan. The study includes a Phase 1a dose escalation period to determine safety and dosing limits, followed by Phase 1b2 periods focusing on selected solid tumors expressing HER2. Treatment schedules and dosing details are designed to monitor tolerability and explore efficacy outcomes over time. During the study, participants undergo various assessments including monitoring for adverse events, dose-limiting toxicities within the first 21 days of treatment, and evaluation of objective response rate, duration of response, progression-free survival, and overall survival for up to two years. Safety evaluations continue up to 30 days after the last dose. Participants provide written informed consent and undergo cardiac function monitoring before treatment, with ongoing evaluations throughout their participation, which lasts as long as the study and follow-up periods continue.

Researchers are evaluating the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 rhPRG4 for people with Sjgrens Syndrome who have dry eye disease. This Phase II, multi-center, randomized, double-masked controlled study is conducted in Australia to compare rhPRG4 to a placebo vehicle. The study aims to help improve symptoms and signs of dry eye related to Sjgrens Syndrome. Participants are randomly assigned to receive either rhPRG4 at a concentration of 450 gml or a PBS-based vehicle control. The treatment is applied topically to the eyes. The study lasts for 28 days, during which participants use the assigned treatment following the prescribed regimen. The trial includes regular assessments to monitor safety and efficacy throughout this period. During the study, participants attend scheduled visits where researchers evaluate eye health using corneal staining tests, symptom questionnaires including the SANDE score and visual analogue scales for dryness and discomfort, and eye examinations such as slit lamp evaluations and intraocular pressure measurements. Safety is monitored by observing any adverse events and changes in vision. The main outcome is the frequency of patients achieving complete resolution of corneal staining by day 28. Participants are asked to adhere to the treatment schedule and attend all visits during the trial duration.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares two doses of NNC0487-0111 given as weekly injections under the skin against a placebo, with the goal of helping participants lose weight and reduce knee pain. Participants have knee osteoarthritis confirmed by clinical and radiographic criteria and will follow a reduced-calorie diet and increased physical activity throughout the study. Participants will be randomly assigned to receive one of three treatments NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, or a placebo, all given once weekly by subcutaneous injection using a pre-filled pen injector. The injections will be administered to the thigh, abdomen, or upper arm. All participants will be encouraged to follow a reduced-calorie diet and increase physical activity during the trial. The treatment period lasts for 80 weeks. Throughout the study, participants will have regular assessments of body weight, knee pain, physical function, and other health measures. Researchers will collect data on changes in weight, knee pain scores using the WOMAC index, physical function, blood pressure, cholesterol levels, blood sugar markers, and use of pain medication. Safety will be monitored through reporting of adverse events. The study is expected to continue until August 2028, with visits and evaluations occurring at scheduled intervals during the treatment period.

Researchers are studying the effects of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for adults with Major Depressive Disorder MDD. This Phase III study aims to evaluate the safety, tolerability, and effectiveness of two different doses of CYB003 alongside participants current antidepressant medications and psychological support. Participants will be randomly assigned to one of three groups one receiving 8 mg of CYB003, another receiving 16 mg of CYB003, or a placebo group. Each participant will undergo two dosing sessions about three weeks apart while continuing their usual antidepressant treatment and receiving manualized psychological support from a facilitator. Non-responders in the placebo group may have the chance to receive CYB003 in an extension trial. During the study, participants will complete several assessments including the Montgomery-Asberg Depression Scale MADRS, Beck Depression Inventory-II BDI-II, Clinical Global Impression Scale CGI-S, Generalized Anxiety Disorder 7-Item Scale GAD-7, and Quality of Life Enjoyment and Satisfaction Questionnaire Q-LES-Q-SF. These evaluations occur at multiple timepoints from screening through the end of the trial. Safety and tolerability will be closely monitored throughout the study, with the total duration lasting approximately 12 weeks from baseline to study end.

Researchers are evaluating the safety, tolerability, early clinical effects, and how the body processes azenosertib ZN-c3 when combined with other drugs in patients with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label study includes patients with platinum-resistant or maintenance therapy contexts, aiming to understand dosing and treatment combinations better. The study has two parts Part 1 assessed azenosertib with chemotherapy drugs including carboplatin, pegylated liposomal doxorubicin PLD, paclitaxel, and gemcitabine in platinum-resistant cases. Part 2 explores azenosertib with bevacizumab as first- or second-line maintenance therapy after platinum chemotherapy. Dose escalation and expansion phases determine recommended doses and evaluate safety. Participants will receive study treatments in combination regimens and undergo regular assessments over about one year. Researchers monitor safety, side effects, and drug levels, aiming to find the maximum tolerated dose and recommended dosing. The study includes clinical evaluations, laboratory tests, and ongoing monitoring of patient response and tolerability throughout the study period.