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Набира участници Фаза 3

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Breast Cancer Locally Advanced Breast Cancer Metastatic Breast Cancer ER Positive Breast Cancer +1

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

Начало: 03.11.2025 Край: 01.01.2032 Възраст: от 18 г. Лечение

Australia, Canada, France +13 Olema Pharmaceuticals, Inc. NCT07085767

Набира участници Фаза 3

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

Neoplastic Disease Glioblastoma Glioblastoma (GBM) Glioblastoma Multiform +2

This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.

Начало: 02.11.2025 Край: 01.11.2027 Възраст: от 18 г. Лечение

Australia, Netherlands Telix Pharmaceuticals (Innovations) Pty Limited NCT07100730

Набира участници

Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

Acute Ischemic Stroke (AIS)

The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)

Начало: 01.11.2025 Край: 01.12.2027 Възраст: 18–75 г.

Australia, France, Germany +1 Penumbra Inc. NCT07107022

Набира участници Фаза 1/2

A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC

Colorectal Cancer (Diagnosis) Colorectal Cancer Metastatic Colorectal Cancer (CRC) Immunotherapy

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg/kg IV infusion Q3W, in participants with pMMR/non-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301. Participants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg/kg IV Q3W will be given in both parts of the study.

Начало: 01.11.2025 Край: 01.07.2028 Възраст: от 18 г. Лечение

Australia, Taiwan Anbogen Therapeutics, Inc. NCT07244705

Набира участници Фаза 3

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Peripheral Arterial Disease

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Начало: 31.10.2025 Край: 01.06.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +13 Eli Lilly and Company NCT07223593

Набира участници Фаза 3

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Non-small Cell Lung Cancer (NSCLC)

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

Начало: 31.10.2025 Край: 29.01.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +16 AstraZeneca NCT07291037

Набира участници

ADHERE Trial: Strategies to Improve Mobile App Adherence

Low Back Pain

This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is: Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain? Participants will: A) Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.

Начало: 30.10.2025 Край: 26.05.2028 Възраст: от 18 г. Лечение

Australia Neuroscience Research Australia NCT07205991

Набира участници Фаза 1/2

A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease

Healthy Volunteers Chronic Kidney Disease

The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is: Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)). Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use. Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.

Начало: 30.10.2025 Край: 01.01.2027 Възраст: 18–60 г. Лечение

Australia Ingenia Therapeutics INC NCT07231679

Набира участници Фаза 3

PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

All-cause Mortality Quality of Life Disability, Intellectual Neurological Disorder +3

This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

Начало: 30.10.2025 Край: 01.12.2029 Възраст: от 18 г. Превенция

Australia, New Zealand The George Institute NCT06819592

Набира участници Фаза 1

A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

Healthy Adult Male

The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are: \- How does Gen-1124 interact with a human body? Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause. Participants will: * Take Gen-1124 for a single dose * Remain in clinic for 2 days for checkups and tests * Recieve a phone call for a checkup 3 and 7 days after the single dose

Начало: 29.10.2025 Край: 01.12.2025 Възраст: 18–55 г. Лечение

New Zealand GEn1E Lifesciences NCT07185113

Набира участници Фаза 3

A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo

Absorption of Omega-3 Omega-3 Supplementation Healthy Participants

This is a randomised, double-blind, parallel, placebo-controlled study in healthy adults to compare the absorption of two microalgal formulations, to a fish oil and a placebo. Participant will take their assigned study product for 6 weeks and attend the clinic for 4 visits.

Начало: 27.10.2025 Край: 01.12.2026 Възраст: 18–64 г. Друго

Australia RDC Clinical Pty Ltd NCT07241377

Набира участници Фаза 3

A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer KRAS G12C Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Начало: 24.10.2025 Край: 31.10.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Hoffmann-La Roche NCT06793215

Набира участници Фаза 1

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

Alopecia Areata

This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).

Начало: 23.10.2025 Край: 10.03.2027 Възраст: 18–75 г. Лечение

Australia, New Zealand Forte Biosciences, Inc. NCT07205159

Набира участници Фаза 2/3

A Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)

Pancreatic Ductal Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

Начало: 23.10.2025 Край: 03.05.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +30 Bristol-Myers Squibb NCT07076121

Набира участници Фаза 3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

Начало: 22.10.2025 Край: 01.08.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +21 Eli Lilly and Company NCT07213804

Набира участници Фаза 2

Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy

Ig-E Mediated Food Allergy

Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. RPT904 is a long-acting antibody that may allow for dosing every 8 to 12 weeks. Approximately 100 participants between the ages of 12 and 55 with documented allergy to at least one of the following foods: peanut, milk, egg, cashew, or walnut will be enrolled. In Part 1 (24 weeks), participants will be randomly assigned to receive RPT904 every 8 or 12 weeks (plus a loading dose at Week 2), or placebo. In Part 2 (24 weeks), participants who received RPT904 will continue on their assigned dosing schedule, and those who previously received placebo will be re-randomized to receive RPT904 either every 8 or 12 weeks (plus a loading dose at Week 26). All participants will attend study visits approximately every 2-6 weeks throughout both Part 1 and Part 2 to maintain blinding, regardless of treatment group or dosing frequency. The study is being conducted at multiple sites. The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic symptoms during a food challenge. The study will also monitor the safety and side effects of RPT904 over time. Each participant is expected to be in the study for about 68 to 74 weeks, including screening, treatment, and follow-up.

Начало: 22.10.2025 Край: 01.01.2028 Възраст: 12–55 г. Лечение

Australia, Canada, United States RAPT Therapeutics, Inc. NCT07220811

Набира участници

SOS for Caregiver Wellbeing

Mental Health Depression and Burden in Caregivers Anxiety Depression Stress +2

Parents and caregivers of children who have a chronic condition carry a large care burden and are at higher risk of having mental health symptoms. This study aims to see if completion of a mental health questionnaire by parents / caregivers at or before the child's paediatric appointment can help identify any symptoms of stress, anxiety or depression. Following the questionnaire, parents / caregivers will be provided with the results of the questionnaire along with an information resource sheet. This will include information on anxiety, stress and depression, as well as different agencies they can contact to get support. Parents / caregivers will be followed up at 3 and 6 months to see if they have any changes to mental health and quality of life, and whether they accessed any support services. The primary aim for this trial is to see whether parents / caregivers find this process acceptable, and whether it can work in a busy hospital clinic.

Начало: 22.10.2025 Край: 28.04.2026 Скрининг

Australia Murdoch Childrens Research Institute NCT07136584

Набира участници Фаза 3

A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

Duchenne Muscular Dystrophy

This is a Phase 3, double-blind, placebo-controlled study with the primary objective of evaluating the efficacy of a single IV infusion of SGT-003 in pediatric ambulant male participants with DMD. The secondary objectives include the evaluation of additional efficacy and safety outcomes. The study will be divided into 2 parts. Participants will be randomized 1:1 to either SGT-003 in Part 1 followed by placebo in Part 2 or to placebo in Part 1 followed by SGT-003 in Part 2. Participants will continue to be monitored in long term follow up (LTFU) for at least 5 years from their SGT-003 dosing date.

Начало: 22.10.2025 Край: 01.01.2034 Възраст: 7–11 г. Лечение

Australia, Canada Solid Biosciences Inc. NCT07160634

Набира участници Фаза 1

A Phase 1b Open-label Study to Evaluate Safety of Plamotamab in Participants With Rheumatoid Arthritis

Rheumatoid Arthritis

The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.

Начало: 21.10.2025 Край: 01.06.2028 Възраст: от 18 г. Лечение

Georgia, Moldova, New Zealand Xencor, Inc. NCT07230353

Набира участници Фаза 3

A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)

Phenylketonuria

The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 2 in 3 (or approximately 67%) chance of receiving JNT-517 during the first part of the study which will last approximately six weeks. During the second part of the study every participant who continues in the study will receive one of two doses of JNT-517 for an additional 46 weeks. The study requires a screening period of up to 35 days to ensure dietary stabilization and amino acid levels required to meet study eligibility. In total, participation in the study could last for up to 400 days. Participants will: Take 75 mg JNT-517 or 150 mg JNT-517, or a placebo BID (2x per day) for approximately 365 days; Visit the clinic or have a mobile health nurse visit your home for checkups and tests; Collect urine sample at home and bring to clinic on specified days; Keep a food diary 3 days before each study visit

Начало: 20.10.2025 Край: 01.04.2028 Възраст: от 18 г. Лечение

Australia, Canada, Czechia +7 Otsuka Pharmaceutical Development & Commercialization, NCT06971731

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