ANZCTR search results

Study Purpose This study aims to evaluate a new investigational treatment called IMD303 to determine a safe dose and understand how the body responds to it in people with advanced solid cancers. Who Can Participate? You may be eligible for this study if you are aged 18 years or older and have an advanced or recurrent solid tumour such as melanoma, non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, or bladder cancer and whose cancer has progressed despite standard treatment, who cannot tolerate standard treatment, or who have chosen not to pursue further standard therapy. Study details Those who are eligible will receive IMD303 as an intravenous infusion on Day 1 of each treatment cycle. Each dose level will include around 3 to 6 participants, and there is an element of chance because participants are enrolled into sequential dose groups depending on when they join the study. Study Duration The anticipated study duration for each participant in Phase 1a is at least four treatment cycles (each cycle is of 21 days). The Safety Monitoring Committee may assess whether the treatment could continue beyond Cycle 8 based on the emerging evidence of clinical benefit (e.g., partial or complete response). Potential Benefits It is hoped that this research will help determine whether IMD303 is safe and how it affects cancer growth, providing important early information that may support the development of new treatment options in the future.

This study will assess the safety and tolerability of a new anti-cancer drug, AN8025, to determine the safest dose that can be given to adults with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an advanced or metastatic cancer, this may be non-small cell lung cancer, melanoma (skin cancer) or another type of cancer that presents as solid tumours. Participants will also need to complete additional health checks by a doctor to determine if it is safe for them to enter this study. Study details All participants who choose to enrol in this study will be given AN8025 once every 3 weeks. Treatment will continue until the body can no longer tolerate the drug, the disease progresses, or the participant decides to stop taking part in the study. Different groups of participants will be enrolled to test higher doses of AN8025, once the starting dose has been determined to be safe. Participants will be asked to provide blood samples and keep a diary of any side effects that they experience after taking AN8025. It is hoped this research will determine that use of AN8025 is safe and tolerable for patients with advanced or metastatic cancer, and that this study will determine the highest safe dose for patients with cancer. Once the safest dose is determined, a larger study enrolling a greater number of cancer patients may go ahead.

This study will investigate the feasibility of a High Fibre Dietary Intervention in patients with Melanoma receiving Neoadjuvant Immune Checkpoint Inhibitors Who is it for? You may be eligible to join this study if you are aged 18 years or above with a histologically or cytologically confirmed diagnosis of Stage III or IV melanoma, naïve to immune checkpoint therapy and planned for neoadjuvant pembrolizumab. Study details All participants in this study will receive a dietician-led dietary counselling intervention over 9 weeks to escalate daily fibre intake to >30g per day. The intervention will be undertaken face to face or via telehealth and will involve provision of resources including recipes and meal plans, fibre-counting tables, and individualised advice. Adherence will be assessed via 3-day food records while safety and tolerance to the dietary intervention will be assessed via questionnaires. This intervention will help establish whether a dietician-led counselling intervention can successfully help escalate fibre intake in an area where a high-fibre diet may be important in improving responses to immune checkpoint therapy.

This study aims to capture information regarding the effect of immune checkpoint inhibitor (ICI) treatment for melanoma on reproductive organ function and sex hormone levels. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with melanoma (Stage II, III or IV) and you are planning to receive ICI treatment. Additional criteria will apply dependent upon your biological sex characteristics. Study details All participants who choose to enrol in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Male participants will also be asked to provide semen samples at 2 of their scheduled treatment visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enrol in this study, this is an observational study only. It is hoped this research will contribute important information regarding the potential toxic effects of ICI treatment on sexual and reproductive function in patients with melanoma who are receiving ICI treatment.

The purpose of this study is to investigate the safety and tolerability of 3D printed intranasal splints in healthy participants. Who is it for? You may be eligible for this study if you are a healthy adult, without a history of surgeries to the nose. Study details All participants in this study will be asked to wear a splint in the nose continuously for 10 days and will be followed up for 30 days to see if there have been any side effects It is hoped this study will help determine if these splints are safe to use for a future randomised trial looking at whether these devices can be helpful in nasal skin cancers

This study aims to determine whether E-EDV-D682 in combination with the adjuvant treatment, EDV-GC is safe and effective and to identify the most responsive cancer indications (advanced EGFR-expressing solid tumors) to the E-EDV-D682/GC treatment. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. A life expectancy greater than 3 months, measurable disease per iRECIST criteria, adequate haematological, renal, hepatic and cardiac function. You must have positive EGFR expression on local IHC or liquid biopsy. Study details In Phase I of the study a safety assessment will be performed on 3 participants from each cancer indication. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 20 participants for each cancer indication. The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with iRECIST to determine treatment response. Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment free week in which tumour burden is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the funding from this study will help determine the safety and efficacy of EGFR targeted EDVs carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate

This study aims to determine the safety, tolerability, pharmacokinetics, preliminary efficacy, and maximum tolerated dose (MTD) of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma. Who is it for? You may be eligible to join this study if you are a male or female aged 18 to 85 years old and have at least a single histologically confirmed nBCC suitable for treatment. A nBCC previously biopsied outside the study as part of standard clinical practice may be re-biopsied within the study, provided that approximately less than 25 percent of the area of the nodular lesion is removed as a result of the second biopsy. Study details All participants who meet the eligibility criteria in this study will receive either a single dose of FLD-103 or multiple doses of FLD-103 once weekly for four (4) weeks. FLD-103 is comprised of two (2) components, FSD147L and PMO-Gli1 formulated as an intralesional injection. During and after completion of the treatment participants will be assessed for safety and tolerability of FLD-103, plasma PK and tumor response. It is hoped the research in the Dose Escalation Phase (Part 1) will determine the maximum dose of FLD-103 that can be administered safely without causing severe reactions. Once Part 1 is completed, Part 2 will then evaluate one or more dose level(s) deemed to be safe and well tolerated, based on the data from the Part 1 of the study. A sentinel subject will be required in each Single Ascending Dose Cohort. . Once all subjects of a Cohort have been dosed, all available safety and tolerability data, from evaluable subjects will be reviewed. Updated due to protocol amendment. Update made after enrollment of 13 participants

This study aims to evaluate the effect on risk-appropriate cancer screening of multi-cancer polygenic risk scores and tailored advice on risk-appropriate cancer screening in general practice. Who is it for? People aged 40-59 years old who are able to read and write in English and currently do not have any alarm symptoms or diagnosis of cancer. All participants must be under the care of a General Practitioner who is participating in the trial. Study Details Participants will be randomly allocated into the intervention or control group. The intervention group will receive an individualised cancer risk report and tailored advice for risk-appropriate screening for melanoma, colorectal, and breast or prostate cancer during a consultation with a researcher . The control group will receive the ‘Cut your Cancer Risk’ brochure and information about lifestyle factors that can impact cancer risk during a consultation with a researcher. This study will contribute to what we know about how individualised risk information can impact peoples' cancer screening behaviours.

The primary purpose of the study is to assess the safety and feasibility of using the Aethlon Hemopurifier in combination with anti-PD-1 therapy (pembrolizumab or nivolumab) for cancer patients with solid tumors. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with non-small cell lung cancer, melanoma, bladder/urinary tract cancer (urothelial cancer), renal cancer, colorectal cancer, gastric or gastroesophageal junction or esophageal cancer, head and neck cancer, cervical cancer or mesothelioma; and are determined by the treating physician to have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab. Study details Participants who choose to enrol in this study will all receive the Aethlon Hemopurifier (HP) treatment, however depending upon the timing of your enrolment you may receive a different dose of the HP treatment. The maximum number of doses you may receive is one 4-hour treatment per day, on alternating days, for a total of up to three doses. You will continue to receive your scheduled pembrolizumab or nivolumab treatment during your participation in this study. It is hoped this research will determine the optimal dosing interval for the Aethlon Hemopurifier treatment and demonstrate that this treatment can decrease the levels of exosoms associated with cancer progression. It is also hoped that the HP treatment may improve cancer patients response to anti-PD-1 therapy (pembrolizumab or nivolumab).

This study assesses the effectiveness of pancreatic screening in identifying early-stage pancreatic cancer among high-risk individuals. Significant emphasis is also placed on assessing the psychological perception of cancer surveillance and understanding its impact on high-risk populations. Who is it for? You may be eligible for this study if you are have relatives with history of PDAC, or high-risk pathogenic variants within the family. Study details Participants will undergo monitoring via endoscopic ultrasound or MRI to detect changes in the pancreas, for a period of 10 years. Participants will be asked to complete an eligibility questionnaire, an enrolment questionnaire and then follow-up questionnaires annually which include updates to the participant’s medical information, relevant risk factors associated with pancreatic cancer, and assessments to determine quality of life, as well as cancer risk perception and worry. It is hoped that findings from this study will help improve the prognosis of pancreatic cancer by diagnosing precursor lesions or cancer in its early and asymptomatic stage, when surgery provides the best chance for a cure.