ANZCTR search results

This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

The study hypothesise that the combination of carboplatin, gemcitabine, bevacizumab and atezolizumab may be synergistic and improve outcomes for patients with early relapsed TNBC by overcoming mechanisms of immune resistance and thus potentiating greater and more durable responses to immune checkpoint inhibitor therapy. Early relapsing TNBC represents a high priority, unmet need whereby effective therapeutic strategies are urgently needed.

This is a Phase II, randomized, placebo-controlled, double-blind, crossover study on the CNS and pharmacodynamic effects of clenbuterol (CST-103) co-administered with nadolol (CST-107) in 4 subject populations with Neurodegenerative Disorders.

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients. We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).

This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement

This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.