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  • A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.

    The duration of study participation will be approximately 6 months for each participant.

    Phase

    1

    Span

    33 weeks

    Sponsor

    Sanofi

    Southport, Queensland

    Recruiting

    Healthy Volunteers

  • A Study to Learn More About How Well Treatment With BAY2927088 Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

    Phase

    2

    Span

    141 weeks

    Sponsor

    Bayer

    Southport, Queensland

    Recruiting

  • A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

    The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

    Phase

    3

    Span

    268 weeks

    Sponsor

    AstraZeneca

    Southport

    Recruiting

  • Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

    TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy. The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by: - Overall survival [OS] - Progression-free survival [PFS] per RECIST 1.1 The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.

    Phase

    3

    Span

    237 weeks

    Sponsor

    Immutep S.A.S.

    Southport

    Recruiting

  • A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

    This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

    Phase

    3

    Span

    255 weeks

    Sponsor

    AstraZeneca

    Southport

    Recruiting

  • Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

    Phase

    3

    Span

    317 weeks

    Sponsor

    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Southport

    Recruiting

  • A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

    Phase

    3

    Span

    172 weeks

    Sponsor

    argenx

    Southport

    Recruiting

  • A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

    Phase

    3

    Span

    140 weeks

    Sponsor

    ModernaTX, Inc.

    Southport, Queensland

    Recruiting

    Healthy Volunteers

  • Efficacy and Safety of HB-1 for Panic Disorder

    This is a multicenter, randomized, double-blind, placebo-controlled trial. All patients with Panic Disorder, with or without specified co-morbidities, who meet all of the inclusion and none of the exclusion criteria will be eligible. Patients and researchers will be blinded to their treatment group. The study will enroll approximately 240 (up to 600) adult patients who meet the diagnosis of panic disorder. Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment.

    Phase

    2

    Span

    70 weeks

    Sponsor

    Honeybrains Biotech LLC

    Southport, Queensland

    Recruiting

  • A Study of DM001 in Patients With Advanced Solid Tumors

    This is a Phase 1, multicenter, openlabel, first-in-human (FIH), doseescalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of DM001 in subjects with advanced solid tumors. DM001, a bispecific ADC developed using fully human antibodies with a common light chain, which targets TROP2 and EGFR. DM001 is sterile yellowish-green lyophilized powder for IV infusion. Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose).

    Phase

    1

    Span

    121 weeks

    Sponsor

    Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

    Southport, Queensland

    Recruiting

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