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Набира участници Фаза 1/2

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

Начало: 05.12.2023 Край: 16.08.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +5 AstraZeneca NCT06106945

Набира участници Фаза 1/2

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

ER+ HER2- Advanced Breast Cancer High-grade Serous Ovarian Cancer (HGSOC)

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

Начало: 05.12.2023 Край: 04.08.2027 Възраст: от 18 г. Лечение

Australia, South Korea, Spain +2 AstraZeneca NCT06188520

Набира участници Фаза 2

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Начало: 05.12.2023 Край: 01.02.2028 Възраст: 18–75 г. Лечение

Australia, Belgium, Canada +10 Gilead Sciences NCT06029972

Набира участници

Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

Valve Stenoses, Aortic

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

Начало: 04.12.2023 Край: 01.08.2026 Възраст: от 18 г. Друго

Australia The Alfred NCT06284837

Набира участници Фаза 3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NASH With Fibrosis MASH With Fibrosis

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Начало: 01.12.2023 Край: 01.11.2032 Възраст: 18–80 г. Лечение

Argentina, Australia, Canada +15 Akero Therapeutics, Inc NCT06215716

Набира участници

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Invasive Fungal Infections

This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Начало: 01.12.2023 Край: 01.04.2027 Възраст: от 18 г.

Australia Peter MacCallum Cancer Centre, Australia NCT06105411

Набира участници Фаза 1

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer Hormone-receptor-positive Breast Cancer +5

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Начало: 01.12.2023 Край: 01.11.2028 Възраст: от 18 г. Лечение

Australia, Brazil, China +8 BeOne Medicines NCT06120283

Набира участници

A Multicenter Multinational Observational Study of Children With Hypochondroplasia

Hypochondroplasia

This study will assess growth over time and the clinical course of HCH in children by collecting growth measurements and other variables of interest.

Начало: 27.11.2023 Край: 31.12.2043 Възраст: до 15 г.

Argentina, Australia, Brazil +8 BioMarin Pharmaceutical NCT06212947

Набира участници Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Locally Advanced Solid Tumors Recurrent Solid Tumors Metastatic Solid Tumors

This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

Начало: 27.11.2023 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia, Canada, Singapore +2 Genentech, Inc. NCT06031441

Набира участници

AusCADASIL: An Australian Cohort of CADASIL

Cadasil

The aim of this project is to establish an Australian cohort of patients diagnosed with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL). This study will examine the clinical features and longitudinal course of CADASIL. Outcome measures include neuropsychological profile, neuroimaging, genetics, blood biomarkers, and retinal imaging.

Начало: 25.11.2023 Край: 31.03.2027 Възраст: от 18 г.

Australia Perminder Sachdev NCT06148051

Набира участници

3D Printed Custom Applicators for HDR BT (DISCO)

Gynecologic Cancer Endometrial Cancer Vaginal Cancer Vulva Cancer

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.

Начало: 24.11.2023 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT06432478

Набира участници Фаза 3

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

Breast Cancer

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Начало: 23.11.2023 Край: 30.09.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +21 AstraZeneca NCT06103864

Набира участници Фаза 4

Antibiotics and Vaccine Immune Responses Study

Vaccine Response Impaired

The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system?

Начало: 23.11.2023 Край: 01.10.2028 Възраст: 18–35 г. Фундаментална наука

Australia South Australian Health and Medical Research Institute NCT06148025

Набира участници Фаза 3

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Metastatic Castration-Sensitive Prostate Cancer

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Начало: 21.11.2023 Край: 30.04.2031 Възраст: 18–130 г. Лечение

Australia, Belgium, Brazil +23 AstraZeneca NCT06120491

Набира участници Фаза 3

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

Breast Neoplasm Female Radiotherapy Cosmetic Outcome

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Начало: 20.11.2023 Край: 01.11.2031 Възраст: 50–120 г. Лечение

Australia, Canada Ontario Clinical Oncology Group (OCOG) NCT05417516

Набира участници Фаза 3

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

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

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Начало: 16.11.2023 Край: 30.09.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Olema Pharmaceuticals, Inc. NCT06016738

Набира участници Фаза 1/2

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

Multiple Myeloma

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

Начало: 14.11.2023 Край: 31.07.2028 Възраст: от 18 г. Лечение

Australia, France, Germany +3 Hoffmann-La Roche NCT05583617

Набира участници Фаза 1/2

A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Solid Tumor

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.

Начало: 14.11.2023 Край: 31.10.2026 Възраст: от 18 г. Лечение

Australia Innovent Biologics (Suzhou) Co. Ltd. NCT05923008

Набира участници Фаза 3

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

Cytomegalovirus (CMV)

The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.

Начало: 13.11.2023 Край: 18.01.2027 Възраст: до 17 г. Лечение

Australia, Belgium, Brazil +8 Takeda NCT05319353

Набира участници Фаза 3

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Unresectable Pleural Mesothelioma

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

Начало: 09.11.2023 Край: 16.11.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +17 AstraZeneca NCT06097728

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