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NCT ID: NCT05876312 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Safety, Tolerability, PK and PD of ADX-038 in HV and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

PNH
Start date: July 3, 2023
Phase: Phase 1
Study type: Interventional

The first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy volunteers (HV) and in patients with paroxysmal nocturnal hemoglobinuria (PNH).

NCT ID: NCT05872295 Recruiting - Breast Cancer Clinical Trials

IKS014 in Advanced Solid Tumors That Express HER2

Start date: September 14, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

NCT ID: NCT05870748 Recruiting - Ovarian Cancer Clinical Trials

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Start date: July 12, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

NCT ID: NCT05870540 Recruiting - Clinical trials for Treatment Resistant Depression

BPL-003 Efficacy and Safety in Treatment Resistant Depression

Start date: September 14, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

NCT ID: NCT05870267 Recruiting - Amputation Clinical Trials

Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb

Start date: October 1, 2021
Phase:
Study type: Observational

This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. The assessment of the inner prosthetic loading will rely on the analyses of common activities of daily living (e.g., walking in straight line and around circles, ascending and descending stairs and slopes, cycling, etc.) performed in experimental and/or clinical and/or open environments. The biomechanical analyses of the load will address the following research questions: A. What is the actual magnitude of the forces and moments applied on transfemoral osseointegrated implant by Rheo Knee and Power Knee during activities of daily living? living? B. What are the determinants of the loading profile in relation to the demographic and anthropometric characteristics, the type and level of activities as well as type, fitting and alignment of Rheo Knee and Power Knee? C. How the loading profiles applied by Rheo Knee and Power Knee compared to usual MPKs and Non-MPK considered below standard of care? Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time). These biomechanical analyses will rely on already published protocols (e.g., study design, instrumentation setup, extraction of loading profile). Protocols to record load data have been well described by PI-Frossard in over 20 peer-review publications in top-ranked journals. The protocol used in this study has been acknowledged, validated and are commonly used within the fields of biomechanics and prosthetics. The outcome of this study will increase the basic understanding about the effects of loading on the interaction between body and prosthesis (e.g., osseointegration between residual bone and implant). The study will also increase applied knowledge required to establish stronger evidence-based rehabilitation programs, fitting of prosthetic limbs and design of bionics prosthetic components. It is anticipated that, both basic and applied knowledge gain in this study will, all together, contribute to increase the health-related quality of life of individuals fitted with socket and bone-anchored prostheses.

NCT ID: NCT05868174 Recruiting - Clinical trials for Advanced Solid Tumor

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.

NCT ID: NCT05868044 Recruiting - Clinical trials for Chronic Cluster Headache

REsponse to Combined SONS and ONS in Chronic Cluster headachE

RESPONSE
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.

NCT ID: NCT05867303 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Start date: June 5, 2023
Phase: Phase 1
Study type: Interventional

Safety study of RC198 in Subjects with Solid Tumors.

NCT ID: NCT05867121 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: October 2, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

NCT ID: NCT05867056 Recruiting - Clinical trials for Hepatitis B, Chronic

Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection

Start date: August 12, 2020
Phase: Phase 1
Study type: Interventional

IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB). This is the first in-human study of IMC-I109V in persons with CHB.