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Набира участници Фаза 1/2

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Thyroid Eye Disease

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Начало: 30.05.2024 Край: 13.08.2027 Възраст: 18–65 г. Лечение

Australia, Canada, France +8 Amgen NCT06401044

Набира участници Фаза 1

Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

Solid Tumor, Adult Bladder Cancer Urothelial Carcinoma Triple-negative Breast Cancer +5

This is an open-label pilot study of a new PET/CT imaging agent MNPR-101-DFO\*-89Zr in patients with solid tumor cancers. These cancers may include bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. MNPR-101-DFO\*-89Zr is made of MNPR-101, a humanized IgG1 monoclonal antibody and a radioisotope Zirconium-89. This imaging agent may show where tumors are present in the body using a PET-scan. Participants will be injected with the radioactive tracer once. After injection, participants will have 3 PET-scans. Each PET-scan will take about 30 minutes. The PET-scans are on separate days within 10 days after injection (e.g., 2 hours after injection, plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10. The study will see if the new imaging agent correctly shows all tumors. In the future, this method may be useful to help predict who will benefit from certain therapies.

Начало: 30.05.2024 Край: 01.04.2026 Възраст: от 18 г. Диагностика

Australia Monopar Therapeutics NCT06337084

Набира участници Фаза 2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Mantle Cell Lymphoma

To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.

Начало: 29.05.2024 Край: 01.03.2027 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06263491

Набира участници Фаза 1

Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

AML With Gene Mutations

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia

Начало: 29.05.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, South Korea, Taiwan +1 Lomond Therapeutics Holdings, Inc. NCT06366789

Набира участници Фаза 1

A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.

Начало: 29.05.2024 Край: 25.02.2029 Възраст: 18–100 г. Лечение

Australia, Belgium, Canada +12 Amgen NCT06360354

Набира участници Фаза 3

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Prader-Willi Syndrome

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech

Начало: 28.05.2024 Край: 01.07.2027 Възраст: от 6 г. Лечение

Australia, Belgium, Canada +9 Harmony Biosciences Management, Inc. NCT06366464

Набира участници Фаза 3

ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients

Breast Carcinoma

Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.

Начало: 27.05.2024 Край: 27.09.2030 Възраст: от 18 г.

France Institut Curie NCT06195709

Набира участници Фаза 3

A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

Non-small Cell Lung Cancer

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab 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). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).

Начало: 24.05.2024 Край: 18.02.2031 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +23 Merck Sharp & Dohme LLC NCT06345729

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Начало: 24.05.2024 Край: 01.08.2031 Възраст: 18–75 г. Лечение

Argentina, Australia, Belgium +20 89bio, Inc. NCT06419374

Набира участници Фаза 3

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Thrombocythemia, Essential Primary Myelofibrosis Myelofibrosis Post-polycythemia Vera Myelofibrosis +2

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Начало: 23.05.2024 Край: 04.12.2034 Възраст: от 18 г. Лечение

Australia, Hong Kong, Italy +3 Merck Sharp & Dohme LLC NCT06351631

Набира участници

CPAx: Responsiveness and Minimal Clinically Important Difference

Muscle Weakness Critical Illness Myopathy Critical Illness Polyneuropathy Critical Illness Polyneuromyopathy +1

Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.

Начало: 23.05.2024 Край: 01.10.2025 Възраст: от 18 г.

Australia, Switzerland Insel Gruppe AG, University Hospital Bern NCT06419699

Набира участници Фаза 2

A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis

Plaque Psoriasis

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis

Начало: 22.05.2024 Край: 01.03.2026 Възраст: от 18 г. Лечение

Australia Zai Lab (Hong Kong), Ltd. NCT06380907

Набира участници Фаза 1

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer NSCLC KRAS G12C +2

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Начало: 22.05.2024 Край: 01.09.2031 Възраст: от 18 г. Лечение

Australia, Canada, Spain +1 TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeuti NCT06343402

Набира участници

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Epilepsy

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.

Начало: 21.05.2024 Край: 31.12.2026 Възраст: от 18 г.

United Kingdom Neuronostics Ltd NCT06097195

Набира участници Фаза 1

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Acute Myeloid Leukemias

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Начало: 21.05.2024 Край: 01.02.2027 Възраст: 18–75 г. Лечение

Australia, Canada, Netherlands +3 Syndax Pharmaceuticals NCT06226571

Набира участници Фаза 3

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

Начало: 21.05.2024 Край: 22.02.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +19 Daiichi Sankyo NCT06203210

Набира участници Фаза 3

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Начало: 21.05.2024 Край: 05.04.2032 Възраст: 12–100 г. Лечение

Argentina, Australia, Brazil +24 Novartis Pharmaceuticals NCT06133972

Набира участници Фаза 1

Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

Начало: 20.05.2024 Край: 30.06.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06015880

Набира участници Фаза 1/2

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

Prostatic Neoplasms, Castration-Resistant

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

Начало: 20.05.2024 Край: 15.01.2029 Възраст: от 18 г. Лечение

Australia, Canada, Chile +16 Merck Sharp & Dohme LLC NCT06353386

Набира участници

Manipulating E-Cigarette Nicotine to Promote Public Health

Tobacco-Related Carcinoma

This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.

Начало: 20.05.2024 Край: 20.05.2027 Възраст: 21–65 г.

United States Ohio State University Comprehensive Cancer Center NCT06448351

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