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Recruiting Phase 1

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers

Healthy

The goal of this clinical trial is to evaluate the safety and tolerability of single and multiple doses of IMP761 in healthy female and male volunteers aged 18-55 with no history of disease affecting the immune system or recent use of medication with effects on the immune system. The main question it aims to answer is: \- if IMP761 is safe and tolerable as determined by assessing vital signs, emerging (serious) adverse events, electrocardiography, and clinical laboratory tests. Researchers will compare IMP761 to a placebo (a look-alike substance that contains no drug) to see if single and multiple doses of IMP761 are safe and tolerable in healthy volunteers. Part B of the study also investigates the effect of IMP761 on the inhibition of the keyhole limpet haemocyanin (KLH) driven immune response compared with placebo. Participants will: * receive IMP761 or a matching placebo intravenously once in single dose (part A and B) and three times in multiple dose (part C) during a 4 day in clinic stay with 4-8 following visits. * receive KLH challenge * be monitored for up to 103 days after the first dose.

Начало: 17.07.2024 Край: 31.08.2026 Възраст: 18–55 г.

Netherlands Immutep S.A.S. NCT06637865

Recruiting Phase 3

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Начало: 17.07.2024 Край: 01.01.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +10 Vor Biopharma NCT06456580

Recruiting Phase 3

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Metastatic Colorectal Cancer

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Начало: 17.07.2024 Край: 31.08.2031 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +30 Amgen NCT06252649

Recruiting Phase 3

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

Essential Thrombocythemia

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Начало: 16.07.2024 Край: 24.03.2028 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +20 Merck Sharp & Dohme LLC NCT06456346

Recruiting Phase 1

A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.

Parkinson Disease

Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Начало: 16.07.2024 Край: 01.10.2025 Възраст: 30–89 г. Treatment

Australia Longevity Biotech Australia Pty Ltd (subsidiary) NCT06466525

Recruiting

Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy

Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN). Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.

Начало: 16.07.2024 Край: 31.01.2027 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06389721

Recruiting Phase 2

Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Metastatic Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Carcinoma Stage IV Nasopharyngeal Carcinoma AJCC v8

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

Начало: 15.07.2024 Край: 30.04.2029 Възраст: от 18 г. Treatment

Australia, Canada, Hong Kong +2 National Cancer Institute (NCI) NCT06029270

Recruiting Phase 1

Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

Onychomycosis

3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.

Начало: 12.07.2024 Край: 01.12.2026 Възраст: 18–60 г.

Egypt Zagazig University NCT06485505

Recruiting Phase 2

A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

Large B-cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Primary Mediastinal Large B-cell Lymphoma (PMBCL) Transformed Non-Hodgkin Lymphoma

The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are: * What is the likelihood of complete response of the lymphoma after WZTL-002 treatment? * What is the risk of altered brain function (neurotoxicity) after WZTL-002? All eligible participants will receive WZTL-002; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies. Participants will: * Have a procedure to gather white blood cells * Receive chemotherapy to prepare for the CAR T-cells * Receive WZTL-002 CAR T-cells through a vein * Be monitored closely for the first 14 days for certain side effects * Have scans 28 days and 3, 6, 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked

Начало: 12.07.2024 Край: 30.06.2028 Възраст: 18–75 г. Treatment

New Zealand Malaghan Institute of Medical Research NCT06486051

Recruiting Phase 1

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers

Idiopathic Pulmonary Fibrosis Lung; Disease, Interstitial, With Fibrosis

This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.

Начало: 11.07.2024 Край: 10.02.2025 Възраст: 18–60 г. Treatment

Australia Shenzhen Resproly Biopharmaceutical Co., Ltd NCT06482190

Recruiting

Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Long Term Follow-up

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

Начало: 11.07.2024 Край: 30.10.2029 Възраст: 20–70 г.

Australia, Hong Kong, Moldova +4 Arbutus Biopharma Corporation NCT06277037

Recruiting Phase 1/2

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.

Начало: 11.07.2024 Край: 31.12.2030 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06287229

Recruiting Phase 2

Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery

Resectable Intrahepatic Cholangiocarcinoma

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Начало: 10.07.2024 Край: 12.02.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06050252

Recruiting

Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor

OSA

The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).

Начало: 10.07.2024 Край: 10.10.2028 Възраст: 20–90 г.

Australia Woolcock Institute of Medical Research NCT06110962

Recruiting Phase 1/2

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Childhood Cancer Childhood Solid Tumor Childhood Brain Tumor Recurrent Cancer +1

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

Начало: 10.07.2024 Край: 01.12.2035 Възраст: до 21 г. Treatment

Australia, Canada Australian & New Zealand Children's Haematology/Oncolog NCT06208657

Recruiting Phase 2

Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).

Buruli Ulcer

The goal of this interventional clinical trial is to determine if treatment with 2-4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included. • Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.

Начало: 09.07.2024 Край: 01.12.2026 Възраст: от 18 г. Treatment

Australia Barwon Health NCT06481163

Recruiting Phase 3

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.

Начало: 09.07.2024 Край: 26.11.2030 Възраст: от 18 г. Treatment

Australia, Belgium, Brazil +13 Servier Bio-Innovation LLC NCT06127407

Recruiting Phase 1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma

B-cell Non Hodgkin Lymphoma

This is an open-label, multiple ascending dose (MAD), phase 1 study in adult patients with relapsed or refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL). The purpose of the study is to identify possible optimal biological dosage(s) by assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics, clinical activity and immunogenicity of SAR448501/DR-0201. The study duration per participant will be approximately 3 years, including a screening period of up to 28 days, a treatment period of 52 weeks, a safety follow-up period of approximately 28 days and a long-term follow-up period of every 3 months until withdrawal of consent, participant death or study closure, whichever is sooner.

Начало: 08.07.2024 Край: 11.02.2028 Възраст: от 18 г. Treatment

Australia, Serbia, Singapore +2 Sanofi NCT06392477

Recruiting Phase 3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Juvenile Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 08.07.2024 Край: 01.10.2028 Възраст: 5–17 г. Treatment

Australia, Canada, France +6 AbbVie NCT06100744

Recruiting

Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Gastroparesis

Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \

Начало: 07.07.2024 Край: 01.06.2026 Възраст: от 18 г.

New Zealand Chris Varghese NCT06381349

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