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Набира участници Фаза 3

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Начало: 26.07.2024 Край: 01.12.2030 Възраст: от 18 г. Лечение

Australia, New Zealand, United States Telix Pharmaceuticals (Innovations) Pty Limited NCT06520345

Набира участници Фаза 1

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

Metastatic Hepatocellular Carcinoma Local Advanced Hepatocellular Carcinoma Alpha-fetoprotein (AFP)-Producing Gastric Cancer Extragonadal Yolk Sac Tumors +1

This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).

Начало: 23.07.2024 Край: 31.12.2026 Възраст: от 18 г. Лечение

China, New Zealand, Puerto Rico +2 BeOne Medicines NCT06427941

Набира участници Фаза 2

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Inflammatory Bowel Diseases Crohn's Disease

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Начало: 18.07.2024 Край: 01.06.2030 Възраст: 18–85 г. Лечение

Australia, Brazil, Bulgaria +22 Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of NCT06226883

Набира участници Фаза 1

A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Locally Advanced Solid Tumor Metastatic Solid Tumor

Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Начало: 18.07.2024 Край: 01.02.2027 Възраст: от 18 г. Лечение

Australia, Canada, United States Nuvalent Inc. NCT06521554

Набира участници Фаза 3

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Начало: 17.07.2024 Край: 01.01.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +10 Vor Biopharma NCT06456580

Набира участници Фаза 1

A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.

Parkinson Disease

Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Начало: 16.07.2024 Край: 01.10.2025 Възраст: 30–89 г. Лечение

Australia Longevity Biotech Australia Pty Ltd (subsidiary) NCT06466525

Набира участници Фаза 2

Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Metastatic Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Carcinoma Stage IV Nasopharyngeal Carcinoma AJCC v8

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

Начало: 15.07.2024 Край: 30.04.2029 Възраст: от 18 г. Лечение

Australia, Canada, Hong Kong +2 National Cancer Institute (NCI) NCT06029270

Набира участници Фаза 2

A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

Large B-cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Primary Mediastinal Large B-cell Lymphoma (PMBCL) Transformed Non-Hodgkin Lymphoma

The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are: * What is the likelihood of complete response of the lymphoma after WZTL-002 treatment? * What is the risk of altered brain function (neurotoxicity) after WZTL-002? All eligible participants will receive WZTL-002; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies. Participants will: * Have a procedure to gather white blood cells * Receive chemotherapy to prepare for the CAR T-cells * Receive WZTL-002 CAR T-cells through a vein * Be monitored closely for the first 14 days for certain side effects * Have scans 28 days and 3, 6, 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked

Начало: 12.07.2024 Край: 30.06.2028 Възраст: 18–75 г. Лечение

New Zealand Malaghan Institute of Medical Research NCT06486051

Набира участници Фаза 1

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers

Idiopathic Pulmonary Fibrosis Lung; Disease, Interstitial, With Fibrosis

This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.

Начало: 11.07.2024 Край: 10.02.2025 Възраст: 18–60 г. Лечение

Australia Shenzhen Resproly Biopharmaceutical Co., Ltd NCT06482190

Набира участници

Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Long Term Follow-up

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

Начало: 11.07.2024 Край: 30.10.2029 Възраст: 20–70 г.

Australia, Hong Kong, Moldova +4 Arbutus Biopharma Corporation NCT06277037

Набира участници

Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor

OSA

The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).

Начало: 10.07.2024 Край: 10.10.2028 Възраст: 20–90 г.

Australia Woolcock Institute of Medical Research NCT06110962

Набира участници Фаза 1/2

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Childhood Cancer Childhood Solid Tumor Childhood Brain Tumor Recurrent Cancer +1

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

Начало: 10.07.2024 Край: 01.12.2035 Възраст: до 21 г. Лечение

Australia, Canada Australian & New Zealand Children's Haematology/Oncolog NCT06208657

Набира участници Фаза 2

Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).

Buruli Ulcer

The goal of this interventional clinical trial is to determine if treatment with 2-4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included. • Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.

Начало: 09.07.2024 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia Barwon Health NCT06481163

Набира участници Фаза 3

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.

Начало: 09.07.2024 Край: 26.11.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +13 Servier Bio-Innovation LLC NCT06127407

Набира участници Фаза 1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma

B-cell Non Hodgkin Lymphoma

This is an open-label, multiple ascending dose (MAD), phase 1 study in adult patients with relapsed or refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL). The purpose of the study is to identify possible optimal biological dosage(s) by assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics, clinical activity and immunogenicity of SAR448501/DR-0201. The study duration per participant will be approximately 3 years, including a screening period of up to 28 days, a treatment period of 52 weeks, a safety follow-up period of approximately 28 days and a long-term follow-up period of every 3 months until withdrawal of consent, participant death or study closure, whichever is sooner.

Начало: 08.07.2024 Край: 11.02.2028 Възраст: от 18 г. Лечение

Australia, Serbia, Singapore +2 Sanofi NCT06392477

Набира участници Фаза 3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Juvenile Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 08.07.2024 Край: 01.10.2028 Възраст: 5–17 г. Лечение

Australia, Canada, France +6 AbbVie NCT06100744

Набира участници

Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Gastroparesis

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \

Начало: 07.07.2024 Край: 01.06.2026 Възраст: от 18 г.

New Zealand Chris Varghese NCT06381349

Набира участници

An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Limb Fracture Bone Loss

Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

Начало: 03.07.2024 Край: 30.03.2029 Възраст: от 18 г.

Australia, Brazil, Chile +11 AO Innovation Translation Center NCT04112992

Набира участници Фаза 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors

Solid Tumors Neoplasms

The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

Начало: 02.07.2024 Край: 20.09.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +11 GlaxoSmithKline NCT06431594

Набира участници Фаза 2

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Diabetic Nephropathies Primary Focal Segmental Glomerulosclerosis Minimal Change Disease Primary Immunoglobulin A Nephropathy +1

This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.

Начало: 02.07.2024 Край: 01.06.2027 Възраст: 18–75 г. Лечение

Australia, India, Malaysia +4 Walden Biosciences NCT06466135

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