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Набира участници Фаза 1

ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies

Acute Myelogenous Leukemia Myelodysplastic Syndromes (MDS)

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.

Начало: 18.12.2024 Край: 01.01.2028 Възраст: от 18 г. Лечение

Australia, China, United States Beijing InnoCare Pharma Tech Co., Ltd. NCT06656494

Набира участници Фаза 3

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

Multifocal Motor Neuropathy (MMN) MMN

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months. More information can be found here: https://clinicaltrials.argenx.com/empassion

Начало: 18.12.2024 Край: 01.12.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +19 argenx NCT06742190

Набира участници Фаза 1

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

Diabetic Macular Edema Diabetic Retinopathy

THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

Начало: 18.12.2024 Край: 28.02.2026 Възраст: 18–80 г. Лечение

Australia Therini Bio Pty Ltd NCT06701721

Набира участници Фаза 1

Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2

Spinocerebellar Ataxia Type 2

Adult participants with spinocerebellar ataxia type 2 (SCA2) who carry ≥33 cytosine, adenine, guanine (CAG) repeats in the ATXN2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose of ARO-ATXN2 or placebo and be evaluated for safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

Начало: 17.12.2024 Край: 01.12.2026 Възраст: 18–65 г. Лечение

Australia, Canada, France +5 Arrowhead Pharmaceuticals NCT06672445

Набира участници Фаза 2/3

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

Metastatic Uveal Melanoma

The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.

Начало: 17.12.2024 Край: 01.10.2031 Лечение

Australia, United Kingdom, United States Replimune, Inc. NCT06581406

Набира участници

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Ultomiris-exposed Pregnant/ Postpartum Pregnancy Paroxysmal Nocturnal Hemoglobinuria (PNH) Atypical Hemolytic Uremic Syndrome (aHUS) +2

The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

Начало: 16.12.2024 Край: 11.07.2034

Australia, France, Germany +4 Alexion Pharmaceuticals, Inc. NCT06312644

Набира участници Фаза 1/2

Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combination dose (RDC) and then will transition to an expansion phase (Phase 2 study) to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin at the RCD. During the treatment period participants will have study visits on days 1, 8, and 15 of Cycle 1, on days 1 and 8 of Cycle 2 to 8, and on day 1 of each additional cycle. Cycles 1 through 8 are 21 day cycles, and each following cycle is 28 days. Approximately 30 days and 90 days after treatment has ended, safety follow-up visits will occur and then participants will be followed for survival every 3 months. Study visits may include blood tests, ECG, vital signs, and a physical examination.

Начало: 16.12.2024 Край: 13.09.2027 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +6 Institut de Recherches Internationales Servier NCT06501625

Набира участници Фаза 1

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Advanced or Metastatic ER+ HER2- Breast Cancer (mBC) Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC) Metastatic Breast Cancer +2

This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors. This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).

Начало: 16.12.2024 Край: 30.08.2027 Възраст: от 18 г. Лечение

Australia, United States Olema Pharmaceuticals, Inc. NCT06784193

Набира участници Фаза 1

Study of BM230 in Patients With Advanced Solid Tumors

Solid Tumor

This study is a Phase I, multicenter, non-randomized, open-label, first-in-human study of BM230 conducted globally. The study will include two parts: a dose escalation part (Phase Ia) followed by a dose expansion part (Phase Ib). Phase Ia part will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors (HER2-related solid tumors). The Phase Ib part will enroll 5 distinct cohorts of patients with advanced solid tumors related to HER2 under MTD/RED doses, to better define the safety profile of BM230 and evaluate the efficacy of BM230.

Начало: 16.12.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, China Suzhou Biomissile Pharmaceuticals Co., Ltd. NCT06644300

Набира участници Фаза 3

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Colorectal Neoplasms

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Начало: 12.12.2024 Край: 13.04.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +23 Janssen Research & Development, LLC NCT06750094

Набира участници Фаза 1/2

Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)

Progressive Multiple Sclerosis

This is an open-label, multi-center, non-confirmatory study to assess the safety, disease progression, and cellular kinetics following YTB323 administration to 28 participants with non-active Progressive Multiple Sclerosis (PMS). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.

Начало: 12.12.2024 Край: 14.06.2030 Възраст: 18–60 г. Лечение

Australia, Canada, France +4 Novartis Pharmaceuticals NCT06675864

Набира участници

A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Benign Prostatic Hyperplasia

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Начало: 12.12.2024 Край: 30.12.2026 Възраст: от 45 г. Лечение

Chile, New Zealand Andromeda Surgical NCT06668142

Набира участници Фаза 3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Начало: 11.12.2024 Край: 30.01.2031 Възраст: 16–80 г. Лечение

Argentina, Australia, Belgium +24 Hoffmann-La Roche NCT06588855

Набира участници Фаза 1/2

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much * How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects) * If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)

Начало: 11.12.2024 Край: 01.11.2035 Възраст: от 18 г. Лечение

Australia, United Kingdom Regeneron Pharmaceuticals NCT06669247

Набира участници

SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation

Difficult Airway Difficult Airway Intubation Neonate

Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \

Начало: 10.12.2024 Край: 01.12.2026 Възраст: 1–52 г. Превенция

Australia, Brazil, Sweden Vinícius C Quintão, MD, MSc, PhD NCT06683599

Набира участници Фаза 2

A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1

Myotonic Dystrophy 1

The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.

Начало: 10.12.2024 Край: 01.08.2026 Възраст: 16–60 г. Лечение

Canada, New Zealand, United Kingdom PepGen Inc NCT06667453

Набира участници

STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision

Vulvar Squamous Cell Carcinoma

This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?

Начало: 10.12.2024 Край: 30.11.2031 Възраст: от 18 г. Лечение

Canada, New Zealand Canadian Cancer Trials Group NCT06358469

Набира участници Фаза 2

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)

Muscle-invasive Urothelial Carcinoma

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

Начало: 09.12.2024 Край: 10.11.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +16 Hoffmann-La Roche NCT06534983

Набира участници Фаза 3

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Metastatic Castration-resistant Prostate Cancer

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Начало: 09.12.2024 Край: 30.07.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +16 Amgen NCT06691984

Набира участници

Using Artificial Intelligence to Screen for Hip Dysplasia

Developmental Dysplasia of Hip

The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia. It will also seek to understand how parents feel about their children undergoing this scan. Participants will: * Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia * Complete a short questionnaire about the experience of having the measurement performed on their child

Начало: 06.12.2024 Край: 01.11.2026 Възраст: 4–20 г. Скрининг

Australia Murdoch Childrens Research Institute NCT06647225

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