Act, Australia

A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01

This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled, parallel group study to evaluate the efficacy of oral doses of VX-01 in subjects with moderate to severe NPDR, without CI-DME. Approximately 100 male and female subjects aged ≥ 18 years with a documented diagnosis of Type 1 Diabetic Mellitus or Type 2 Diabetic Mellitus with moderate to severe NPDR (without CI-DME) will be enrolled, if they meet all the eligibility criteria for the study. Subjects will be randomized 1:1 to 1 of 2 study cohorts: - Cohort 1 (n = 50): VX-01 (film-coated tablets, 150 mg administered BID) - Cohort 2 (n = 50): Placebo (film-coated tablets, administered BID) Subjects will be stratified by the presence or absence of proliferative diabetic retinopathy (PDR) and by glycated hemoglobin (HbA1c) of ≥ 8.5% or < 8.5% at Screening. All subjects will take 1 tablet of VX-01 or placebo BID for 52 consecutive weeks. All subjects will be followed for 12 weeks after completion of treatment at Week 52. The Sponsor, study site staff, monitors, personnel, and subjects will be masked to treatment assignment during the entirety of the study.

YN001-004 in Patients With Coronary Atherosclerosis in Australia

This is a multicenter, randomized, open label, parallel-group, proof of concept study. It is designed to determine if the study drug, called YN001, administered in addition to evolocumab can effectively reduce the total amount of plaque formed in the coronary artery as measured by CCTA from baseline to week 13. A total of 12 patients with coronary atherosclerosis are expected to be enrolled and will be randomly assigned in a 1:1 ratio to 1 of 2 YN001 treatment arms (6 patients per arm) with 2 different dose levels for 12 weeks. The study will be comprised of a maximum 41-day screening period (Day -42-Day -2), a baseline period (Day-1), a treatment and observation period (W1D1- W13D7), and a safety follow-up period (14 days post last dose).

Working Out M0 Bipolar Androgen Therapy

This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer. Adults with castrate resistant prostate cancer, with no evidence of metastatic disease (M0) on conventional imaging [Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening] and prostate specific antigen (PSA) only progression on darolutamide may be eligible. Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment. It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)

A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized). Who is it for? Participant may be eligible for this study if participant is an adult who has cancer of the esophagus or gastro-esophageal junction that is locally advanced or has spread to other parts of the participant's body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary esophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy. After this participants will continue to receive immune therapy (durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed. Safety blood tests will be collected throughout the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). CT scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically throughout the study. It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body's immune system to prevent worsening of the cancer and improve swallowing.

A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

SON-1010 may work best with an immune checkpoint inhibitor (ICI), particularly with tumors that are high in the 'secreted protein acidic and rich in cysteine' (SPARC), like ovarian cancer. Immunotherapy combinations can present different toxicities, so the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab and the recommended Phase 2 dose (RP2D) will initially be established in patients with advanced solid tumors in Part 1, with the subset of patients with platinum-resistant ovarian cancer (PROC) used in the top 2 dose cohorts. This will be followed in Part 2 with an assessment in patients with PROC of the potential for improved efficacy of the combination over SON-1010 alone, vs. the standard of care (SOC).

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

Patients who are enrolled in the MoST or CaSP cancer screening programs, and whose tumour is assessed as amenable to tiragolumab and atezolizumab treatment, will be recommended for participation in the study. After being informed about the study, and the potential risks, patients who consent to participate undergo a 21-day screening period to determine study eligibility. Patients will be prospectively selected into subgroups based on their tumour characteristics. Once eligibility is confirmed, tiragolumab alone is administered at Cycle 1 Day 1 (day 1 of study). Commencing from Cycle 2 Day 1, tiragolumab and atezolizumab are administered at 21-day cycles until treatment discontinuation, with or without disease progression. Participants undergo a biopsy at cycle 2 prior to commencement of atezolizumab treatment. Standard imaging scans (usually computed tomography (CT)) are performed throughout the trial. Patients also undergo blood, urine and stool sample collection on study. Once participants discontinue treatment, a study visit is performed within 30 days of the end of the final treatment cycle. If treatment cessation is not contemporaneous with disease progression, follow-up calls are conducted every 9 weeks until disease progression. Once disease progression occurs, a study visit is performed within 30 days of disease progression and then every 3 months until 12 months after the final participant discontinues study treatment. Active follow-up of all participants will continue until death or 12 months after the last participant discontinues study treatment, whichever occurs first. Subsequently, survival data will be obtained through MoST or CaSP until death.