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  • Long-term Safety of Nipple Sparing Mastectomy in Women With GPV in Breast Cancer

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Sir Mortimer B. Davis - Jewish General Hospital

    Melbourne

    Recruiting

  • Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

    Phase

    1/2

    Span

    203 weeks

    Sponsor

    Immunocore Ltd

    Melbourne

    Recruiting

  • A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

    PTX-100 from a Phase I study shown to help some CTCL patients. This Phase II study will be conducted in a larger population size and there will be initially two groups/arms in the first phase called Phase 2a. This phase will randomize and enroll 20 subjects into the 500 mg/m2 and 20 subjects into the 1000 mg/m2 PTX treatment arms. After determining the recommended optimal dose from phase 2a, for Phase 2b, 75 subjects will then be allocated into this single arm part of the study. Once subject has signed the informed consent, subject will undergo a 28 day screening period, where eligibility would be determined. Once subject is eligible, subject will be dosed with IP. Safety bloods will be taken on the first day of every cycle. Pharmacokinetics (PKs) which are blood samples sent to the Sponsors associated laboratory and will be analysed on how PTX-100 interacts biologically. PKs will be taken on Cycle1Day1(C1D1) to C1D5 and C1D8 for the first 4 cycles. Subject will also undergo skin evaluation and safety exams at every Cycle Day 1. Subjects will also complete quality of life questionnaires at every Cycle Day1. Subjects will be on the study for 18months, until disease progression, unacceptable toxicity, participant or Investigator decision, or until study treatment discontinuation criteria are met, whichever occurs first.

    Phase

    2

    Span

    170 weeks

    Sponsor

    Prescient Therapeutics, Ltd.

    Melbourne, Victoria

    Recruiting

  • A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia

    Phase

    1/2

    Span

    96 weeks

    Sponsor

    Design Therapeutics, Inc.

    Melbourne, Victoria

    Recruiting

  • A New Website for Australian IVF Patients: 'Evidence-based IVF'

    In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.

    Phase

    N/A

    Span

    11 weeks

    Sponsor

    University of Melbourne

    Melbourne, Victoria

    Recruiting

  • ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

    ORIC-114, is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR exon 20 insertion mutations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases. Amivantamab is a bispecific EGFR-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and also as a single agent in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is an open-label, single arm, multicenter, dose escalation followed by dose expansion study to assess the safety and preliminary antitumor activity of ORIC-114 in combination with SC amivantamab, in patients with locally advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutations.

    Phase

    1

    Span

    118 weeks

    Sponsor

    ORIC Pharmaceuticals

    Melbourne, Victoria

    Recruiting

  • A Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

    Phase

    1

    Span

    174 weeks

    Sponsor

    Janssen Research & Development, LLC

    Melbourne

    Recruiting

  • Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants

    Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is one of the most common causes of autoimmune encephalitis. The disease is caused by the development of autoantibodies against the amino (N)-terminal domain (NTD) of the NMDAR subunit 1 (NR1) that bind and cross link the receptors, leading to receptor internalization and loss of function. Arialys has developed a monovalent (one-armed) antibody, ART5803, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor. In treating anti-NMDAR encephalitis, intravenous immunoglobulin (IVIG) is commonly administered in conjunction with corticosteroids. Consequently, it is anticipated that IVIG may be administered to the target population prior to ART5803. IVIG has a long half-life and competitive binding of IVIG to the neonatal fragment crystallization receptor (FcRn) may result in FcRn saturation. This can potentially lead to increased clearance and/or impaired tissue distribution of ART5803 and decrease the cerebrospinal fluid (CSF) exposure to ART5803 through competition on FcRn at the blood-brain barrier (BBB).

    Phase

    1

    Span

    37 weeks

    Sponsor

    Arialys Therapeutics

    Melbourne, Victoria

    Recruiting

    Healthy Volunteers

  • A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients

    All subjects that will be enrolled in this investigation should have been treated with the OPRA TM Implant System for a transhumeral unilateral or bilateral amputation completed before 01-Jan-2024. This retrospective, non-interventional, clinical investigation is designed as a multicenter, multinational, cohort investigation for long-term follow-up of safety and efficacy endpoints. The investigation will also include prospective visit(s) for enrollment of subjects and collection of present data on device functionality and the use of the device. No control group or comparator will be used in this investigation. All patient reported outcome questionnaires used in the investigation will be available at the investigation site for completion by the subjects during one of the subjects' visits to the site. Depending on the subjects' preferences it will also be possible to provide those questionnaires to the subjects, through use of regular mail, email or through an electronic Patient Reported Outcome system (ePRO). It will be possible for the subjects to complete the questionnaires either on paper, electronically or over phone, depending on their preferences. Preferably, the subjects prosthesis functional tests should be performed as part of the follow-up visit at the site. The tests may also be performed remotely, depending on subjects' preferences. If done remotely, this will require the functionality test being performed during a videoconference with the test administrator. No photos or video-recordings (if conducted according to the sites normal practice) of the performed tests will be part of the investigation documentation, only the related medical record notes will be used as source data for those parameters.

    Phase

    N/A

    Span

    58 weeks

    Sponsor

    Integrum

    Melbourne, Victoria

    Recruiting

  • SNV4818 in Participants With Advanced Solid Tumors

    Phase

    1

    Span

    97 weeks

    Sponsor

    Pikavation Therapeutics, Inc.

    Melbourne, Victoria

    Recruiting

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