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Набира участници Фаза 2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

Начало: 06.12.2024 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Brazil, China +7 Johnson & Johnson Enterprise Innovation Inc. NCT06667908

Набира участници

Closed-loop in Adults With Type 2 Diabetes

Type 2 Diabetes Treated With Insulin

The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes. This is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices. The primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol/L) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \& closed-loop usage, questionnaires and semi-structured interviews.

Начало: 06.12.2024 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia, Czechia, France +2 University of Cambridge NCT06579404

Набира участници Фаза 2

BMB-101 in Absence Epilepsy and DEE

Absence Epilepsy Jeavons Syndrome Dravet Syndrome Lennox Gastaut Syndrome

The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Absence Epilepsy including Epilepsy with Eyelid Myoclonia (also called Jeavons Syndrome) as well as Developmental Epileptic Encephalopathies such as Dravet and Lennox Gastaut. The study will last up to 6 months. There will be a 1 month screening period, then up to 3 months on open-label BMB-101 including titration and tapering/washout periods, and then a 1 month follow-up period. There will be 6 clinic visits.

Начало: 05.12.2024 Край: 30.11.2025 Възраст: 18–65 г. Лечение

Australia Bright Minds Biosciences Pty Ltd NCT06401538

Набира участници Фаза 1

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

Multiple Myeloma

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses \[RP2Ds\]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Начало: 04.12.2024 Край: 23.11.2028 Възраст: от 18 г. Лечение

Australia, Israel, Netherlands +1 Janssen Research & Development, LLC NCT06768489

Набира участници Ранна Фаза 1

G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies

Travelers Diarrhea

The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401. The main questions it aims to answer are: * What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material? * Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug? Researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated. Each study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.

Начало: 04.12.2024 Край: 02.12.2025 Възраст: от 19 г. Фундаментална наука

Australia Lumen Bioscience, Inc. NCT06556940

Набира участници Фаза 3

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

Antibody-mediated Rejection

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment * Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year * Changes in kidney function from the start of treatment * How many people have biopsy results showing their kidney tissue looks normal again * How long the transplanted kidney keeps working * How many participants have medical problems during the study * How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52 * How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time * How felzartamab is processed by the body * How many participants develop antibodies against felzartamab in the blood The study will be done as follows: * Participants will be screened to check if they can join the study. This will take up to 42 days. * There will be 2 parts in this study. * Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo. * Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab. * All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight. * Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.

Начало: 03.12.2024 Край: 01.06.2027 Възраст: 18–75 г. Лечение

Argentina, Australia, Brazil +8 Biogen NCT06685757

Набира участници Фаза 3

Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) Myelodysplastic Syndromes (MDS)

This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.

Начало: 03.12.2024 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Brazil, France +7 Institut de Recherches Internationales Servier NCT06465953

Набира участници Фаза 2

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Chronic Kidney Disease

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Начало: 02.12.2024 Край: 17.09.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +11 Novo Nordisk A/S NCT06717698

Набира участници Фаза 1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Chronic Hep B Chronic Hepatitis b Chronic Hepatitis HBV

This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.

Начало: 29.11.2024 Край: 30.10.2028 Възраст: 18–75 г. Лечение

Hong Kong, Moldova, New Zealand Tune Therapeutics, Inc. NCT06671093

Набира участници Фаза 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Non-squamous Non-small Cell Lung Cancer

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Начало: 27.11.2024 Край: 25.03.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 AstraZeneca NCT06627647

Набира участници Фаза 1/2

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

B-cell Malignancy Relapsed Cancer Refractory Cancer B-cell Lymphoma

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Начало: 27.11.2024 Край: 02.12.2029 Възраст: от 18 г. Лечение

Australia, Brazil, China +5 BeOne Medicines NCT06634589

Набира участници Фаза 2

Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

B-cell Non-Hodgkin Lymphoma Follicular Lymphoma (FL) Large B-Cell Lymphoma (LBCL)

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.

Начало: 27.11.2024 Край: 14.06.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +12 AstraZeneca NCT06526793

Набира участници Фаза 1

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

Metastatic Solid Tumors Advanced Non-squamous Non-small-cell Lung Cancer Advanced Colorectal Cancer Advanced Pancreatic Ductal Adenocarcinoma +3

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

Начало: 26.11.2024 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, China, New Zealand +2 BeiGene NCT06585488

Набира участници Фаза 1

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Advanced Solid Tumor

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.

Начало: 25.11.2024 Край: 31.12.2026 Възраст: от 18 г. Лечение

Australia, United States Adcendo ApS NCT06597721

Набира участници Фаза 1

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

Healthy Adult Volunteers Active Ulcerative Colitis Active Ulcerative Colitis (UC)

This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate injection after subcutaneous (SC) injection of multiple doses in healthy adults and in the ulcerative colitis (UC) patient population.

Начало: 25.11.2024 Край: 05.05.2025 Възраст: 18–60 г. Лечение

Australia NIBEC Co., Ltd. NCT06681389

Набира участници Фаза 1

A Phase 1 Study of FZ008-145 in Healthy Subjects.

Healthy

The study will be conducted in 5 parts: Part A (single ascending dose \[SAD\] in solution formulation), Part C (food effect \[FE\]), Part D (cold pressor test \[CPT\] to evaluate pain tolerance following single dose), and Part E (multiple ascending dose \[MAD\] in tablet formulation).

Начало: 25.11.2024 Край: 01.06.2026 Възраст: 18–65 г. Лечение

Australia Guangzhou Fermion Technology Co., LTD NCT06685809

Набира участници Фаза 3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Gastroesophageal-junction Cancer Monoclonal Antibody Gastric Cancer HER2-positive Gastric Cancer

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Начало: 22.11.2024 Край: 01.09.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +14 Shanghai Henlius Biotech NCT06532006

Набира участници Фаза 2

A Basket Study of Vosoritide in Children With Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment

Short Stature Homeobox- Containing Gene SHOX Deficiency Noonan Syndrome Turner Syndrome

The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.

Начало: 22.11.2024 Край: 01.09.2041 Възраст: 3–11 г. Лечение

Australia, France, Italy +2 BioMarin Pharmaceutical NCT06668805

Набира участници Фаза 2/3

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Начало: 22.11.2024 Край: 30.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT05552157

Набира участници Фаза 2/3

A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease Dementia Alzheimers Disease, Familial

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Начало: 22.11.2024 Край: 01.08.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Washington University School of Medicine NCT06647498

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