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Набира участници Фаза 1

ARC101 in Advanced Solid Tumors

Advanced Solid Tumor

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.

Начало: 05.02.2025 Край: 01.08.2028 Възраст: от 18 г. Лечение

Australia, Canada, Israel +1 Third Arc Bio NCT06672185

Набира участници Фаза 1/2

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Lung Cancer Breast Cancer

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Начало: 04.02.2025 Край: 26.02.2031 Възраст: от 18 г. Лечение

Australia, Canada, Chile +6 Bristol-Myers Squibb NCT06618287

Набира участници Фаза 3

A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

Pyoderma Gangrenosum

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Начало: 04.02.2025 Край: 01.02.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +15 Boehringer Ingelheim NCT06624670

Набира участници Фаза 1

BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

Hormone-receptor-positive Breast Cancer HER2-negative Breast Cancer Metastatic Breast Cancer

This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.

Начало: 04.02.2025 Край: 30.07.2027 Възраст: от 18 г. Лечение

Australia, China, United States BeOne Medicines NCT06756932

Набира участници Фаза 3

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Extensive-stage Small-cell Lung Cancer

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Начало: 03.02.2025 Край: 01.03.2029 Възраст: от 18 г. Лечение

Australia, China, Germany +7 BioNTech SE NCT06712355

Набира участници

Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer

Breast Cancer Surgery

Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing mastectomy (SSM) techniques, nipple sparing mastectomy (NSM) is associated with improved psychosocial and sexual well-being and is significantly better for body image and reducing feelings of disfigurement. Despite this, guidelines have yet to endorse the use of NSM over other RRM techniques, stating that more data and longer follow-up are needed to confirm it as a safe and effective strategy in GPV carriers. As NSM was not routinely adopted in high-risk patient populations undergoing RRM before 2010, there has been little data to inform the long-term oncologic safety of NSM. Well-designed studies have reported low to negligible rates of subsequent breast cancer in BRCA1/2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1/2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.

Начало: 01.02.2025 Край: 01.02.2028 Възраст: 18–90 г.

Australia, Belgium, Canada +2 Sir Mortimer B. Davis - Jewish General Hospital NCT06888388

Набира участници Фаза 3

Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE

Hereditary Angioedema (HAE)

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

Начало: 01.02.2025 Край: 01.12.2028 Възраст: от 12 г. Лечение

Australia, Bulgaria, Canada +10 Pharvaris Netherlands B.V. NCT06679881

Набира участници Фаза 3

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)

Hidradenitis Suppurativa

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).

Начало: 31.01.2025 Край: 18.01.2028 Възраст: 12–100 г. Лечение

Argentina, Australia, Bulgaria +15 Novartis Pharmaceuticals NCT06799000

Набира участници Фаза 1/2

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Chronic Lymphocytic Leukaemia Small Lymphocytic Lymphoma Mantle-cell Lymphoma Large B-cell Lymphoma +1

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Начало: 30.01.2025 Край: 11.06.2029 Възраст: от 18 г. Лечение

Australia, China, Czechia +9 AstraZeneca NCT06564038

Набира участници Фаза 1

Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D

Diabetes

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) biomarkers in single ascending doses (SAD), food effect, and multiple doses studies of RZ-629 in healthy participants and T2D.

Начало: 30.01.2025 Край: 20.02.2026 Възраст: 18–65 г. Лечение

Australia Rezubio Pharmaceuticals Co., Ltd. NCT06829563

Набира участници Фаза 2/3

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Metastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Начало: 28.01.2025 Край: 01.07.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +10 Bicara Therapeutics NCT06788990

Набира участници Фаза 2/3

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Narcolepsy Type 1 Narcolepsy Type 2 Idiopathic Hypersomnia

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Начало: 27.01.2025 Край: 01.06.2028 Възраст: 18–70 г. Лечение

Australia, Belgium, Czechia +5 Alkermes, Inc. NCT06767683

Набира участници

Prehabilitation for Patients Undergoing Lung Cancer Surgery

Lung Cancer (NSCLC)

Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.

Начало: 24.01.2025 Край: 30.06.2025 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT06716437

Набира участници

Assessment of Breathing Pattern During NIV

COPD (Chronic Obstructive Pulmonary Disease) Obesity Hypoventilation Syndrome (OHS)

COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth. However, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.

Начало: 24.01.2025 Край: 01.09.2025 Възраст: от 18 г. Фундаментална наука

New Zealand Fisher and Paykel Healthcare NCT06682286

Набира участници Фаза 1

A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors

Solid Tumours Sarcoma HNSCC Non Small Cell Lung Cancer +8

The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab. This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more patients completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 5 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 pancreatic adenocarcinoma (OKN4395 alone), Cohort 3 in non-small cell lung cancer (NSCLC), Cohort 4 in colorectal cancer, and Cohort 5 in head \& neck squamous cell carcinoma (HNSCC), with cohorts 3 to 5 in combination with pembrolizumab. The monotherapy expansion Cohort 1 will also be used to explore the effect of food on the levels of OKN4395 in the blood. Similarly, Cohort 2 will be used to explore the effect of gastric pH on the levels of OKN4395 in the blood. The overall study will enrol approximately 166 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 100 participants in Part 1b split: 40 on monotherapy and 60 on combination therapy. The study will be conducted in the US, Australia, UK and in the EU.

Начало: 23.01.2025 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia, United Kingdom, United States Epkin NCT06789172

Набира участници Фаза 2

Long-Term PEA Safety Study

Healthy Safety

The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation. Participants will: * Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process. * Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study. * Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call. * During visits there will be safety assessments performed, blood sampling and questionnaires. The trial will include two participation modes: 1. In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility. 2. Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.

Начало: 22.01.2025 Край: 01.06.2027 Възраст: от 18 г. Друго

Australia RDC Clinical Pty Ltd NCT06717867

Набира участници

Implementing Surgery School Prehabilitation Using Telehealth

Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery

The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences. The STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery. The secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival. This trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 35 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.

Начало: 22.01.2025 Край: 01.07.2028 Възраст: от 18 г. Поддържаща грижа

Australia University of Melbourne NCT06631872

Набира участници Фаза 3

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Chronic Graft-versus-host-disease

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Начало: 21.01.2025 Край: 31.03.2030 Възраст: от 12 г. Лечение

Australia, Canada, Denmark +8 Incyte Corporation NCT06585774

Набира участници Фаза 1

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

SLE SLE (Systemic Lupus)

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Начало: 21.01.2025 Край: 01.12.2027 Възраст: 18–70 г. Лечение

Australia, Bulgaria, Georgia +2 Cullinan Therapeutics Inc. NCT06613360

Набира участници Фаза 1

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

Advanced Solid Tumors

The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.

Начало: 21.01.2025 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, China Shandong Suncadia Medicine Co., Ltd. NCT06770569

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