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Набира участници Ранна Фаза 1

Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients

Atherosclerotic Cardiovascular Disease Acute Coronary Syndromes

The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)/pharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its potential efficacy in patients. Researchers will compare UDP-003 to a placebo in a blinded manner. This first in human, randomised, double-blind, placebo-controlled, prospective, single-centre trial with a modular dose-finding design will be conducted in 3 parts: * Part 1: 6 cohorts of 6 healthy participants receiving Single Ascending Doses (SADs), * Part 2: 3 cohorts of 12 healthy participants receiving Multiple Ascending Doses (MADs) (6 doses over 16 days), * Part 3: 1 cohort of 12 participants diagnosed with acute coronary syndrome (ACS; non-ST elevation myocardial infarction \[NSTEMI\] or unstable angina) at least 12 months post-event receiving multiple doses (6 administrations of the 25 mg/kg dose over 16 days). The planned duration of the study for each participant will be: * 4 weeks for SAD Participants (1-day treatment period, 4-week safety follow-up) * 6 weeks for MAD Participants (16-day treatment period,4-week safety follow-up) * 28 weeks for MD Patients (6-week treatment period, 6-month safety follow-up) Prior to participants being randomised to panels of increasing doses, all safety data will be reviewed for completed panels.

Начало: 25.02.2025 Край: 30.06.2027 Възраст: 18–79 г. Лечение

Australia Cyclarity Therapeutics, Inc. NCT06813339

Набира участници Фаза 3

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Sjögren's Syndrome

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Начало: 25.02.2025 Край: 11.12.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Amgen NCT06747949

Набира участници Фаза 1

A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors

Solid Cancer

This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.

Начало: 24.02.2025 Край: 30.08.2028 Възраст: 18–75 г. Лечение

Australia Akeso NCT06730386

Набира участници Фаза 1/2

A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults

Japanese Encephalitis Virus Disease

This is a 2-Stage, Phase I/II Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)

Начало: 24.02.2025 Край: 19.03.2028 Възраст: от 18 г. Превенция

Australia, New Zealand SK Bioscience Co., Ltd. NCT06680128

Набира участници

Capstan Medical TMVR Study: FIH

Mitral Regurgitation

This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.

Начало: 24.02.2025 Край: 01.12.2030 Възраст: от 18 г. Устройства

Australia, Chile, New Zealand Capstan Medical NCT06600191

Набира участници Фаза 1/2

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

Advanced Solid Tumors

This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.

Начало: 24.02.2025 Край: 01.01.2028 Възраст: от 18 г. Лечение

Australia, China CStone Pharmaceuticals NCT06741644

Набира участници Фаза 1/2

An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis

This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.

Начало: 24.02.2025 Край: 01.10.2030 Възраст: 18–60 г. Лечение

Australia, France, Germany +3 Novartis Pharmaceuticals NCT06617793

Набира участници Фаза 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease

Parkinson Disease

The main goal of this clinical trial is to learn about the safety and tolerability of GT-02287. The questions it aims to answer are: * What medical problems do participants have when taking GT-02287? * How is GT-02287 absorbed, distributed, and removed from the body of participants over time (pharmacokinetics)? * Are there any biological effects of GT-02287 in blood and in cerebrospinal fluid that could be beneficial for people with Parkinson's disease? Participants will: * visit the clinic to assess if they qualify for the study (30-day Screening Period) * if eligible, receive GT-02287 once a day every day for 90 days (90-day Open Label Treatment period) * visit the clinic the first day of treatment, after the first 2 weeks of treatment, and every month during the 90-day Treatment Period. * visit the clinic to assess how they are doing 14 days after the end of GT-02287 treatment (14-day Follow-Up Period).

Начало: 21.02.2025 Край: 30.11.2025 Възраст: 30–85 г. Лечение

Australia Gain Therapeutics, Inc. NCT06732180

Набира участници Фаза 1/2

SNV4818 in Participants With Advanced Solid Tumors

Advanced Solid Tumors

This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.

Начало: 20.02.2025 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, Canada, United States Pikavation Therapeutics, Inc. NCT06736704

Набира участници

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

Amputation of Upper Limb

This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to \>20 years in function. It will collect and evaluate clinical data on the safety and performance of the OPRA™ Implant System when used on transhumeral amputees and within the scope of the intended use.

Начало: 19.02.2025 Край: 01.03.2026 Лечение

Australia, Belgium, Germany +1 Integrum NCT06753110

Набира участници Фаза 1

A Study of DM002 in Patients With Advanced Solid Tumors

Ovarian Neoplasms Prostatic Neoplasms Endometrial Neoplasms Colorectal Neoplasms +1

The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.

Начало: 17.02.2025 Край: 18.04.2028 Възраст: от 18 г. Лечение

Australia, United States Xadcera Biopharmaceutical (Suzhou) Co., Ltd. NCT06751329

Набира участници Фаза 1

A Study of VRN101099 in Patients With HER2-Positive Solid Tumors

HER2-positive Solid Tumors

This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are available.

Начало: 17.02.2025 Край: 31.07.2027 Възраст: от 18 г. Лечение

Australia Voronoi, Inc NCT06806982

Набира участници Фаза 2

A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Advanced Solid Tumors HER2 Mutation

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

Начало: 13.02.2025 Край: 25.10.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +8 Bayer NCT06760819

Набира участници Фаза 1/2

A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

Advanced Solid Tumors

This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.

Начало: 12.02.2025 Край: 09.12.2029 Възраст: от 18 г. Лечение

Australia, Canada, United States Bristol-Myers Squibb NCT06730750

Набира участници Ранна Фаза 1

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

HER2 Gene Mutation Advanced Solid Tumors

This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 consisting of an Imaging Period with 177Lu-RAD202im(imaging dose) and a Treatment Period with 177Lu-RAD202tr(treatment dose) to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.

Начало: 12.02.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia Radiopharm Theranostics, Ltd NCT06824155

Набира участници Фаза 2

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

Diabetic Retinopathy NPDR - Non Proliferative Diabetic Retinopathy

The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR). The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.

Начало: 11.02.2025 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia, Hong Kong, Malaysia +2 Vantage Biosciences Ltd NCT06770933

Набира участници

Locally Optimised Contouring With AI Technology for Radiotherapy

Contouring Segmentation Radiation Therapy Artificial Intelligence +1

LOCATOR is a multicentre phase II randomised clinical trial that is looking at the process of contouring in radiation treatment for breast cancer patients. This study looks at whether contouring aided by artificial intelligence (AI) is comparable in quality to that of contouring done completely manually by a radiation oncologist. We are also looking at whether AI assisted contouring saves radiation oncologists time when compared to fully manual contouring. LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data.

Начало: 11.02.2025 Край: 30.04.2030 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT06546592

Набира участници Фаза 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

Advanced Cancer Advanced Solid Tumor

TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.

Начало: 10.02.2025 Край: 01.12.2028 Възраст: 18–75 г. Лечение

Australia, United States Shanghai Allink Biotherapeutics Co., Ltd. NCT06707610

Набира участници

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

Benign Prostatic Hyperplasia

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

Начало: 10.02.2025 Край: 31.12.2032 Възраст: от 45 г. Лечение

Australia, United States Rivermark Medical NCT06849258

Набира участници Фаза 1/2

A Study Assessing HMB-002 in Participants With Von Willebrand Disease

Von Willebrand Disease (VWD) Von Willebrand Disease (VWD), Type 1 Von Willebrand Disease (VWD), Type 2

This is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study of HMB-002 in participants with VWD. Part A of the study involves a single ascending dose (SAD) design to establish safety, tolerability, PK, and PD effect. In Part B of the study, the safety and tolerability of repeat dosing will be established prior to cohort expansion to explore efficacy.

Начало: 06.02.2025 Край: 01.07.2027 Възраст: 18–64 г. Лечение

Australia, United Kingdom Hemab ApS NCT06754852

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