Province Sud, New Caledonia

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention

The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.

Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty

SB17170 Phase 2 Trial in IPF Patients

Idiopathic pulmonary fibrosis (IPF) is a progressive respiratory disease characterized by a scarring process of the lung, bringing patients to respiratory failure and death in 3-5 years from diagnosis. Subjects who meet the inclusion/exclusion criteria as a result of the screening test shall be randomized into Test Group 1 (SB17170 A mg), Test Group 2 (SB17170 B mg) and Control Group (Placebo for SB17170) in 2:2:1. Subjects who have been randomized will orally take 2 capsules once daily after a meal according to their assigned administration group for 12 weeks from the date they are prescribed the investigational product. Safety and tolerability at 12 weeks after randomization, and efficacy at 4 & 12 weeks will be assessed. The subject who has completed 12 weeks of treatment shall visit the trial site after 1 week (Visit 7, EOS) for a follow-up.

A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Volrustomig Priming Regimens Exploratory Phase II Platform Study

This is a platform, randomized, open-label, multicenter, global study. Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease. These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B. Both arms will test a volrustomig dosing in combination with chemotherapy.

ELVN-002 with Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

Parts 1 and 3 of this study are designed to evaluate preliminary safety, tolerability, and pharmacokinetics (PK) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. In addition, Part 3 will evaluate the preliminary efficacy of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive solid tumors. Part 2 of this study will evaluate the preliminary safety, tolerability, and PK of ELVN-002 in combination with trastuzumab and chemotherapy; capecitabine and oxaliplatin(CAPEOX) or 5-fluorouracil (5-FU), leucovorin (LCV) and oxaliplatin (mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer, or eribulin or capecitabine in participants with advanced-stage HER2-positive breast cancer, or paclitaxel in participants with advanced stage solid tumors. In part 4, the preliminary safety, tolerability, PK, and efficacy of ELVN-002 in combination with trastuzumab and CAPEOX or mFOLFOX6 will be evaluated in participants with HER2-positive colorectal cancer.

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy versus Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment

A multicenter, prospective, comparative, randomized, independent rater-blind, superiority, pivotal clinical trial to compare the safety and efficacy of the Cognitive therapy software 'SUPERBRAIN DEX' for improving cognitive function with a control group for patients with mild cognitive impairment