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Набира участници Фаза 1

Study of IMC-P115C in Advanced PRAME-Positive Cancers

PRAME Positive Cancer HLA-A*02:01-positive

Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.

Начало: 07.11.2024 Край: 30.08.2029 Възраст: от 18 г. Лечение

Australia, France, Italy +1 Immunocore Ltd NCT07156136

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Accelerated Flap Coverage in Severe Lower Extremity Trauma

Open Tibia Fracture Open Dislocation of Ankle Extremity Fracture Lower Extremity Injuries Lower

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

Начало: 04.11.2024 Край: 01.02.2030 Възраст: от 18 г. Лечение

Australia, Spain, United States Johns Hopkins University NCT06293469

Набира участници Фаза 1/2

An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).

Advanced Solid Tumor

This open label, dose escalation module will evaluate the safety, tolerability, PK, PD, and preliminary efficacy of PTT-4256 in participants with solid tumours using a combination of accelerated dose titration (ADT) and Bayesian Optimal Interval (BOIN) design.

Начало: 04.11.2024 Край: 30.10.2027 Възраст: от 18 г. Лечение

Australia Pathios Therapeutics Pty Ltd NCT06634849

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The 5-FU Holter Study

Gastrointestinal Malignancy

To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy

Начало: 01.11.2024 Край: 01.01.2026 Възраст: от 18 г. Диагностика

New Zealand University of Auckland, New Zealand NCT06538610

Набира участници Фаза 1

Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Age-Related Macular Degeneration

This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.

Начало: 31.10.2024 Край: 01.03.2026 Възраст: от 50 г. Лечение

Australia Benobio Co., Ltd. NCT05803785

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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Prostate Cancer

Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.

Начало: 31.10.2024 Край: 31.12.2027 Възраст: от 18 г. Превенция

Australia, United States Palette Life Sciences, Inc. NCT06496256

Набира участници Фаза 1

89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma

Soft Tissue Sarcoma

Soft Tissue Sarcoma (STS) is a type of cancer that develops in soft tissues such as muscles, tendons, fat, blood vessels, and nerves. STSs generally express a protein called Platelet-Derived Growth Factor Receptor (PDGFR)α, which makes them a target for the development of STS therapies, such as olaratumab. Olaratumab has been identified as a promising candidate to which radioactive substances can be attached for imaging or therapeutic purposes. Thus, this first in human imaging trial aims to study olaratumab combined with a radioactive metal called zirconium-89 (89Zr-TLX300-CDx) as a potential new product that may be used for STS imaging and identification of patients that may benefit from future treatments targeting PDGFRα.

Начало: 31.10.2024 Край: 01.08.2026 Възраст: от 18 г. Диагностика

Australia Telix Pharmaceuticals (Innovations) Pty Ltd NCT06537596

Набира участници Фаза 1

A Study of DM005 in Patients With Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of Head and Neck Solid Carcinoma

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.

Начало: 31.10.2024 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia, United States Doma Biopharmaceutical（Suzhou）Co., Ltd. NCT06515990

Набира участници Фаза 1

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo

Alopecia Areata Vitiligo

This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

Начало: 30.10.2024 Край: 01.09.2026 Възраст: от 18 г. Лечение

Australia, New Zealand, United States Dren Bio NCT06602232

Набира участници Фаза 1

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

Hypercholesterolemia Hypertriglyceridemia Refractory Hyperlipidemia

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia. VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Начало: 30.10.2024 Край: 01.12.2027 Възраст: 18–70 г. Лечение

Australia, Canada, South Africa +1 Verve Therapeutics, Inc. NCT06451770

Набира участници Фаза 1

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

Plasma Cell Myeloma Refractory

This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

Начало: 30.10.2024 Край: 16.05.2031 Възраст: от 18 г. Лечение

Australia, Canada, France +4 Sanofi NCT06630806

Набира участници Фаза 2

Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

Cytomegalovirus Viraemia

This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.

Начало: 29.10.2024 Край: 01.12.2028 Възраст: 1–18 г. Лечение

Australia, New Zealand Murdoch Childrens Research Institute NCT06574789

Набира участници Фаза 2

Efficacy and Safety of HB-1 for Panic Disorder

Panic Disorder Mental Illness

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.

Начало: 29.10.2024 Край: 01.02.2027 Възраст: 18–65 г. Лечение

Australia HB BioTech, LLC NCT06483789

Набира участници Фаза 2

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

Scleroderma, Diffuse

The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.

Начало: 29.10.2024 Край: 30.08.2032 Възраст: 18–70 г. Лечение

Australia, Brazil, Czechia +13 Novartis Pharmaceuticals NCT06655896

Набира участници Фаза 1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Solid Tumor, Adult Metastatic Breast Cancer Advanced Breast Cancer HER2 Mutation-Related Tumors +7

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Начало: 29.10.2024 Край: 01.11.2028 Възраст: от 18 г. Лечение

Australia, France, Spain +1 TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeuti NCT06625775

Набира участници Фаза 3

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Crohns Disease Colitis, Ulcerative Arthritis, Psoriatic Arthritis, Juvenile

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Начало: 29.10.2024 Край: 12.12.2031 Възраст: от 3 г. Друго

Argentina, Australia, China +10 Janssen Research & Development, LLC NCT06663332

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Eating Disorders Genetics Initiative 2

Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Avoidant Restrictive Food Intake Disorder

The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.

Начало: 28.10.2024 Край: 01.08.2027 Възраст: 12–99 г.

Australia, Mexico, New Zealand +2 University of North Carolina, Chapel Hill NCT06594913

Набира участници Фаза 1/2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

Advanced Cancer Advanced Solid Tumors

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.

Начало: 24.10.2024 Край: 22.04.2028 Възраст: 18–75 г. Лечение

Australia, China Shanghai Allink Biotherapeutics Co., Ltd. NCT06656390

Набира участници Фаза 1/2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Healthy Volunteers, Pulmonary Arterial Hypertension

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Начало: 24.10.2024 Край: 31.12.2028 Възраст: 18–100 г. Лечение

Australia, Brazil, Czechia +9 Novartis Pharmaceuticals NCT06649110

Набира участници Фаза 1

A Study of DM001 in Patients With Advanced Solid Tumors

Breast Neoplasms Carcinoma, Non-Small-Cell Lung Solid Carcinoma

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.

Начало: 24.10.2024 Край: 13.02.2027 Възраст: от 18 г. Лечение

Australia, United States Xadcera Biopharmaceutical (Suzhou) Co., Ltd. NCT06475937

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