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NCT ID: NCT06350097 Recruiting - Clinical trials for Non-small Cell Lung Cancer

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

TROPION-Lung14
Start date: April 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet) monotherapy as 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 Datopotamab Deruxtecan 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, IP discontinuation or primary PFS DCO. Participants who are receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

NCT ID: NCT06345703 Recruiting - Healthy Subjects Clinical Trials

First-into-human Study of NS-136 in Healthy Subjects

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are: - Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen? - What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?

NCT ID: NCT06344104 Recruiting - Clinical trials for Resistant Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

BaxAsia
Start date: April 8, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

NCT ID: NCT06343402 Recruiting - Clinical trials for Non-small Cell Lung Cancer

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

Start date: May 22, 2024
Phase: Phase 1
Study type: Interventional

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer

NCT ID: NCT06343142 Recruiting - Clinical trials for Cognitive Performance

Effects of Time of Day and Nut Intake on Cognitive Performance

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance.

NCT ID: NCT06342713 Recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Start date: June 3, 2024
Phase: Phase 1
Study type: Interventional

This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants. Study details include: - The study duration will be up to 16 months. - The treatment duration will be up to 14 days. - Safety follow-up 30 days after last dose of study drug.

NCT ID: NCT06339190 Recruiting - Dementia Clinical Trials

Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

NAVAIDD
Start date: August 1, 2021
Phase:
Study type: Observational

This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests. Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months. Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.

NCT ID: NCT06337084 Recruiting - Colorectal Cancer Clinical Trials

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

Start date: April 10, 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (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 amount of radioactivity injected will range between 37-74 MBq (±10%).

NCT ID: NCT06335849 Recruiting - Herpes Zoster Clinical Trials

A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years

Start date: March 27, 2024
Phase: Phase 1
Study type: Interventional

This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.

NCT ID: NCT06334211 Recruiting - Healthy Clinical Trials

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers

Start date: April 16, 2024
Phase: Phase 1
Study type: Interventional

This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers.