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Набира участници Фаза 1/2

S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP

MTAP-deleted Solid Tumors

This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.

Начало: 29.04.2024 Край: 31.10.2031 Възраст: от 18 г. Лечение

Australia, Denmark, France +4 Servier Bio-Innovation LLC NCT06188702

Набира участници Фаза 3

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Non-small Cell Lung Cancer

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 9 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

Начало: 29.04.2024 Край: 25.05.2032 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +16 AstraZeneca NCT06350097

Набира участници

A Platform Trial for Gram Negative Bloodstream Infections

Gram-negative Bacteremia

BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance. The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.

Начало: 24.04.2024 Край: 01.04.2028 Възраст: до 130 г. Лечение

Australia, Canada, Colombia +2 Sunnybrook Health Sciences Centre NCT06537609

Набира участници Фаза 3

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Osteogenesis Imperfecta

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

Начало: 22.04.2024 Край: 25.08.2027 Възраст: 5–17 г. Лечение

Australia, Belgium, Canada +14 Amgen NCT05972551

Набира участници Фаза 3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Non-Muscle Invasive Bladder Neoplasms

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Начало: 18.04.2024 Край: 31.12.2032 Възраст: от 18 г. Лечение

Argentina, Austria, Belgium +16 Janssen Research & Development, LLC NCT06319820

Набира участници Фаза 3

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Crohn's Disease

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Начало: 17.04.2024 Край: 06.03.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +11 Janssen-Cilag Ltd. NCT06408935

Набира участници Фаза 3

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Breast Neoplasms

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Начало: 14.04.2024 Край: 12.04.2031 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +33 Merck Sharp & Dohme LLC NCT06312176

Набира участници Фаза 3

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

Heart Failure and Impaired Kidney Function

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Начало: 12.04.2024 Край: 11.06.2027 Възраст: 18–130 г. Лечение

Argentina, Australia, Brazil +35 AstraZeneca NCT06307652

Набира участници Фаза 1

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

Advanced Solid Tumor

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Начало: 12.04.2024 Край: 15.05.2028 Възраст: от 18 г. Лечение

Australia, Brazil, China +2 BeOne Medicines NCT06233942

Набира участници Фаза 3

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Non-Small Cell Lung Cancer

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Начало: 11.04.2024 Край: 28.12.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +17 AstraZeneca NCT06357533

Набира участници Фаза 2

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Recurrent or Metastatic Solid Tumors

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.

Начало: 10.04.2024 Край: 25.07.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +14 Daiichi Sankyo NCT06330064

Набира участници Фаза 2/3

Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Начало: 10.04.2024 Край: 01.10.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Chile +9 AbbVie NCT06236438

Набира участници

Feasibility Study of a Group Intervention for Youth Wellbeing

Psychological Distress Trauma, Psychological Emotional Problem

Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population. The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.

Начало: 10.04.2024 Край: 01.12.2025 Възраст: 12–19 г. Здравни услуги

New Zealand University of Otago NCT05030909

Набира участници Фаза 1/2

An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency

Ornithine Transcarbamylase Deficiency Ornithine Transcarbamylase Deficiency Disease Ornithine Carbamoyltransferase Deficiency (Disorder) Urea Cycle Disorders, Inborn

Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia. Individuals with OTC deficiency can develop elevated levels of ammonia in the blood, potentially resulting in severe consequences, including cumulative and irreversible neurological damage, coma, and death. The most severe form presents shortly after birth and occurs more commonly in boys than girls. This is a Phase 1/2/3, open-label, multicenter study evaluating the safety, efficacy, and dose of ECUR-506 in male babies with neonatal-onset OTC deficiency. The primary objective is to evaluate the safety, tolerability, and efficacy of up to three dose levels of ECUR-506 following intravenous (IV) administration of a single dose.

Начало: 08.04.2024 Край: 01.12.2027 Възраст: 24–7 г. Лечение

Australia, Spain, United Kingdom +1 iECURE, Inc. NCT06255782

Набира участници Фаза 1

A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects

Healthy Volunteers

The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. The purpose of Part 2 is to assess the safety, tolerability, PK and efficacy of SAD of SC administered FB1003 in adult subjects with osteoarthritis (OA) pain.

Начало: 07.04.2024 Край: 30.05.2026 Възраст: 18–75 г. Лечение

Australia 4B Technologies Limited NCT06343714

Набира участници Фаза 1/2

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Acne

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.

Начало: 05.04.2024 Край: 31.08.2028 Възраст: 18–45 г. Лечение

Australia, Canada, United States Sanofi Pasteur, a Sanofi Company NCT06316297

Набира участници

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Aortic Aneurysm, Abdominal

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Начало: 05.04.2024 Край: 01.06.2031 Възраст: от 18 г. Лечение

France, Netherlands, New Zealand +2 Shape Memory Medical, Inc. NCT06029660

Набира участници Фаза 3

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Non Small Cell Lung Cancer

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Начало: 03.04.2024 Край: 23.10.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +26 Merck Sharp & Dohme LLC NCT06312137

Набира участници

Image Enhanced Endoscopy IBD

Inflammatory Bowel Diseases Dysplasia

Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.

Начало: 03.04.2024 Край: 01.03.2026 Възраст: 18–75 г. Диагностика

Australia Royal Perth Hospital NCT06266104

Набира участници Фаза 1

A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

Non-Muscle-Invasive Bladder Cancer (NMIBC)

This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.

Начало: 03.04.2024 Край: 31.08.2028 Възраст: 18–75 г. Лечение

Australia Ractigen Therapeutics. NCT06351904

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