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Набира участници Фаза 1/2

EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

Prostate Cancer Metastatic Castration-resistant Prostate Cancer

This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).

Начало: 29.09.2022 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT05521412

Набира участници Фаза 1

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Non-muscle-invasive Bladder Cancer NMIBC Non-Muscle Invasive Bladder Carcinoma Non-Muscle Invasive Bladder Neoplasms +2

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Начало: 26.09.2022 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia, United States Aura Biosciences NCT05483868

Набира участници Фаза 2/3

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Начало: 23.09.2022 Край: 18.06.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +15 Janssen Research & Development, LLC NCT05327114

Набира участници Фаза 3

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Начало: 20.09.2022 Край: 30.11.2033 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +24 Celgene NCT05519085

Набира участници Фаза 1

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Prostate Cancer Metastatic Castration-resistant Prostate Cancer Castration Resistant Prostatic Cancer

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Начало: 15.09.2022 Край: 01.12.2028 Възраст: 18–100 г. Лечение

Australia, United States Janux Therapeutics NCT05519449

Набира участници

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Cardiovascular Diseases Acute Coronary Syndrome Atherosclerosis Hypercholesterolemia

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

Начало: 15.09.2022 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, China, India +6 Stephen Nicholls NCT05325034

Набира участници Фаза 3

A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

Prostate Cancer

This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.

Начало: 09.09.2022 Край: 01.06.2030 Възраст: от 18 г. Лечение

Ireland, New Zealand, United Kingdom Institute of Cancer Research, United Kingdom NCT05613023

Набира участници Фаза 3

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Multiple Myeloma

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Начало: 08.09.2022 Край: 01.04.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +19 European Myeloma Network B.V. NCT05243797

Набира участници Фаза 3

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Hypereosinophilic Syndrome

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

Начало: 06.09.2022 Край: 19.12.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +17 GlaxoSmithKline NCT05334368

Набира участници Фаза 1/2

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1

Myotonic Dystrophy Type 1 (DM1)

The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 4 periods: A Screening Period (up to 8 weeks), a Placebo-Controlled Period (24 weeks), a Treatment Period (24 weeks) and a Long-Term Extension (LTE) Period (168 weeks) in both multiple-ascending dose (MAD) and dose expansion cohorts.

Начало: 05.09.2022 Край: 01.07.2029 Възраст: 18–65 г. Лечение

Australia, France, Germany +5 Dyne Therapeutics NCT05481879

Набира участници Фаза 1/2

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Advanced Solid Tumors

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.

Начало: 01.09.2022 Край: 18.02.2032 Възраст: от 12 г. Лечение

Australia, Spain, United Kingdom +1 ModernaTX, Inc. NCT05533697

Набира участници Фаза 1

Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis

Amyloidosis; Systemic

This is a multicenter, international, three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers and in subjects with systemic amyloidosis and to assess the safety, tolerability, and PK of multiple doses of AT-02 in subjects with systemic amyloidosis.

Начало: 01.09.2022 Край: 01.03.2025 Възраст: от 18 г. Лечение

Australia, United States Attralus, Inc. NCT05521022

Набира участници Фаза 1

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Metastatic Breast Cancer ER-positive Breast Cancer HER2-negative Breast Cancer Breast Cancer +1

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Начало: 31.08.2022 Край: 31.01.2028 Възраст: от 18 г. Лечение

Australia, United States Olema Pharmaceuticals, Inc. NCT05508906

Набира участници

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Rotator Cuff Injuries

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Начало: 30.08.2022 Край: 30.06.2028 Възраст: от 18 г. Лечение

Australia, Canada, Italy +3 Smith & Nephew, Inc. NCT05444465

Набира участници Фаза 3

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.

Начало: 30.08.2022 Край: 31.12.2028 Възраст: от 12 г. Лечение

Australia, Brazil, Canada +8 Hoffmann-La Roche NCT05271409

Набира участници Фаза 1/2

Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

HER2-Positive Solid Tumor

This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.

Начало: 26.08.2022 Край: 30.04.2028 Възраст: от 18 г. Лечение

Australia, South Korea, United States Yuhan Corporation NCT05523947

Набира участници

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

Breast Cancer

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Начало: 24.08.2022 Край: 01.12.2037 Възраст: от 50 г. Лечение

Australia, Netherlands Amsterdam UMC, location VUmc NCT05350722

Набира участници

PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury

Trauma, Brain

Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.

Начало: 14.08.2022 Край: 01.07.2025 Възраст: от 18 г.

Australia Australian and New Zealand Intensive Care Research Cent NCT05855252

Набира участници Фаза 1/2

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

This is a Phase 1b/2, multicenter, open-label, study of prizloncabtagene autoleucel (prizlo-cel), an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

Начало: 12.08.2022 Край: 29.03.2029 Възраст: от 18 г. Лечение

Australia, Canada, Denmark +5 Janssen Research & Development, LLC NCT05421663

Набира участници Фаза 2/3

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV

The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.

Начало: 08.08.2022 Край: 01.01.2027 Възраст: от 18 г. Лечение

Australia, Belgium, France +6 Panbela Therapeutics, Inc. NCT05254171

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