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A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients with Early Alzheimer*s Disease (Hetero/Homozygote APOE4 Carriers)

The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…

Virtual Reality to Assess How Boys with Mild to Borderline Intellectual Disabilities Behave in Social Situations

The first aim is to investigate whether SIP indicators measured with VR are better predictors of aggression in real-life than SIP indicators measured with hypothetical vignettes in youth with MID-BIF. The second aim is to explore whether we can…

Exendin PET/CT for imaging of paragangliomas

The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localizing and characterizing PGL.

A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety,Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects with Tenosynovial Giant Cell Tumor

The objectives of this study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT)

Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study (ACT-Study)

Objective: Evaluation of safety and initial efficacy of a novel fusion-protein based anti-COVID19 vaccine in healthy volunteers.

Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

Valemetostat tosylate may modify epigenetic changes, which plays an important role in the pathogenesis of PTCL. In the ongoing open-label Phase 1 study (DS3201-A-J101, 25 Dec 2019 data cut-off), valemetostat tosylate monotherapy demonstrated…

A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel Cell Carcinoma - the MERKLIN 1 Study

Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…

Neo-adjuvant FOLFOXIRI and chemoradiotherapy for high risk (*ugly*) locally advanced rectal cancer.

This study has been transitioned to CTIS with ID 2023-509758-74-00 check the CTIS register for the current data. The aim of this study is to assess the effectiveness of the addition of neoadjuvant induction FOLFOXIRI systemic therapy to…

Mental Health Promotion and Intervention in Occupational Settings: A Pilot Study

The project aims to improve mental health and wellbeing in the workplace by developing, implementing and evaluating an intervention targeting both clinical (depressive, anxiety disorders) and non-clinical (stress, burnout, depressive symptoms)…

Effectiveness of Somatostatin Analogues in patients with Gastric antral
vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial

Primary Objective: To investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by…

A Phase IIb open-label, multi-centre, extension study to explore the long-term safety and efficacy of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation who have completed the KHENERGYZE study KH176-202.

The primary objective of this study is to enable continued treatment with the study drug sonlicromanol for patients who have completed study KH176-202 and to investigate the safety and tolerability of sonlicromanol over an 12 months treatment period…

Resuscitation for repair of endothelial permeability in endotoxemia

The main objective of the proposed study is to investigate the effect of plasma products and albumin on markers of endothelial function in a human endotoxemia model.

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic
Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

This study has been transitioned to CTIS with ID 2023-506987-15-00 check the CTIS register for the current data. 1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response…

Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence
Guided Anatomical Liver Resection: A Feasibility Study

Primary objective: To investigate the feasibility of using intraarterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.Secondary Objective(s): 1. To investigate the dosage which provides sufficient…

Targeting metabolic flexibility in ALS (MetFlex); safety and tolerability of trimetazidine for the treatment of ALS;An investigator initiated and conducted, multicentre, international, open-label Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND)

The objectives of this study are to determine:• The safety and tolerability of trimetazidine in patients with ALS/MND• The change from baseline in oxidative stress markers in patients with ALS/MND after the initiation of trimetazidine• The change…

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN -145) in Patients with Metastatic Non-Small-Cell Lung Cancer

This study has been transitioned to CTIS with ID 2024-510778-26-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of LN-145 measured by objective response rate (ORR) usingResponse Evaluation Criteria in…

Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis

This study has been transitioned to CTIS with ID 2024-515964-30-00 check the CTIS register for the current data. • Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is…

Open Label Phase 2 Study
Neo-Adjuvant BRAF/MEK Inhibition Followed by Surgery and Adjuvant BRAF/MEK Inhibition in In-transit Melanoma Metastases (NASAM)

Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…

A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with advanced and metastatic gastrointestinal cancer

Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…