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Набира участници Фаза 2

Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis

Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study to assess vamifeport in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH). The primary objective of the study is to assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with HFE-HH.

Начало: 22.01.2026 Край: 06.04.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +13 CSL Behring NCT07332091

Набира участници Фаза 1

Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee

Osteoarthritis of the Knee

This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.

Начало: 22.01.2026 Край: 01.12.2026 Възраст: 20–75 г. Лечение

Australia Avidence Therapeutics NCT07338266

Набира участници Фаза 1

A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors

Solid Tumours

A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.

Начало: 21.01.2026 Край: 30.01.2028 Възраст: от 18 г. Лечение

Australia AP Biosciences Inc. NCT07165067

Набира участници Фаза 1

A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

Lymphoma, Non-Hodgkin

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) at the putative RP2D(s) (Part 2: Dose Expansion).

Начало: 20.01.2026 Край: 31.08.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Turkey (Türkiye) Janssen Research & Development, LLC NCT07308132

Набира участници Фаза 1/2

EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors

Advanced Solid Tumors MSI-H or dMMR Advanced Solid Tumors MSI-H/dMMR Gastric Cancer MSI-H/dMMR Colorectal Cancer +3

The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.

Начало: 20.01.2026 Край: 01.03.2029 Възраст: от 18 г. Лечение

Australia, New Zealand, United States Eikon Therapeutics NCT07262619

Набира участници

CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System

Microsurgery Lymphedema Free Tissue Transfer

The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: Allow the researchers to access and use their information. If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. Participants will be asked to comply with the follow-up visits as outlined in the protocol.

Начало: 20.01.2026 Край: 20.01.2029 Възраст: 18–100 г. Друго

Australia MMI (Medical Microinstruments, Inc.) NCT06866197

Набира участници Фаза 2

A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.

Colorectal Cancer

This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.

Начало: 16.01.2026 Край: 30.04.2027 Възраст: от 18 г. Лечение

Australia, United States Kahr Bio Australia Pty Ltd NCT07235293

Набира участници Фаза 3

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Non-small Cell Lung Cancer

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation). Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits. Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.

Начало: 16.01.2026 Край: 02.09.2036 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Boehringer Ingelheim NCT07195695

Набира участници Фаза 1

A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

IDH1-Mutated Malignancies

The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.

Начало: 14.01.2026 Край: 31.08.2028 Възраст: от 18 г. Лечение

Australia, Brazil, Czechia +3 Servier Bio-Innovation LLC NCT07006688

Набира участници Фаза 1

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants

Healthy

The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY8931 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY8931 in healthy adult participants? * What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants? Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated. Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.

Начало: 14.01.2026 Край: 01.10.2026 Възраст: 18–45 г. Друго

Australia Newsoara Biopharma Co., Ltd. NCT07281703

Набира участници Фаза 3

A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma

Multiple Myeloma Secondary Immunodeficiency

Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy. Participants will be randomly assigned to one of two groups: 1. Primary infection prevention group: They will receive IGI, 10% for 12 months. 2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period. During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period of up to 8 weeks).

Начало: 14.01.2026 Край: 11.09.2028 Възраст: от 18 г. Превенция

Australia, Denmark, Greece +7 Takeda NCT06980480

Набира участници Фаза 1

A First-in-human Trial of GRT7041 in Healthy Participants

Treatment of Pain

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants. The trial duration will be up to approximately 6 weeks for participants in Part 1 (Single ascending dose \[SAD\]), except for participants taking part in the food effect cohort SAD3 where the trial duration will be up to approximately 8 weeks. The trial duration will be up to approximately 7 weeks in Part 2 (Multiple ascending dose \[MAD\]), and the Treatment Period will be up to 14 days (for Part 2). The trial will include a Screening Visit, an in-house stay period and Follow-up (FU) Visit/End-of-Trial (EoT) Visit.

Начало: 14.01.2026 Край: 28.08.2026 Възраст: 18–60 г. Лечение

New Zealand Grünenthal GmbH NCT07289776

Набира участници Фаза 1/2

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Начало: 13.01.2026 Край: 02.08.2032 Възраст: от 18 г. Лечение

Australia, China, France +8 Novartis Pharmaceuticals NCT07190300

Набира участници

A Long Term, Observational Follow-Up Study of Children and Young People Who Underwent an 18-Month Course of Oral Immunotherapy Treatment for Peanut, Egg or Milk Allergy (5-15 Years Post-Treatment)

Food Allergies Peanut Allergies Egg Allergy Milk Allergy

The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to: • Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not. Participants will attend a single follow-up visit for: * A blood test * Skin prick test (SPT) * Allergy questionnaires

Начало: 13.01.2026 Край: 01.01.2027

Australia Murdoch Childrens Research Institute NCT07359183

Набира участници Фаза 3

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

Diabetes Mellitus, Type 1

The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

Начало: 12.01.2026 Край: 01.07.2031 Възраст: 1–35 г. Лечение

Australia, Belgium, Brazil +14 Eli Lilly and Company NCT07222137

Набира участници Фаза 1

Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies

Type 1 Interferonopathies

Open-Label Study (Phase Ib) of Type 1 Interferonopathy patients receiving IMSB301 monotherapy.

Начало: 12.01.2026 Край: 30.07.2026 Възраст: от 12 г. Лечение

Australia ImmuneSensor Therapeutics Inc. NCT07364513

Набира участници Фаза 1

Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis

ALS (Amyotrophic Lateral Sclerosis)

This clinical study is in participants with Amyotrophic Lateral Sclerosis and is designed to evaluate the safety and tolerability of the gene therapy CTx1000.

Начало: 12.01.2026 Край: 01.12.2030 Възраст: 18–80 г. Лечение

Australia Celosia Therapeutics Pty Ltd NCT07401121

Набира участници Фаза 1/2

A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors

Advanced Solid Tumors

This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard treatments or refused the existing treatments. This study is divided into a dose-escalation phase (Phase I) and a dose-expansion phase (Phase II). Phase I (dose escalation) is designed to preliminarily evaluate the safety and tolerability of VIB305 in advanced solid tumors, to determine the nature and incidence of dose-limiting toxicities (DLTs), and thereby to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Based on the findings from the Phase I portion for evaluation in the Phase II portion. Phase II (dose expansion) will enroll additional cohorts to further assess the safety and tolerability, PK profile, preliminary antitumor activity and immunogenicity of VIB305 in specific tumor types (selected based on all available data).

Начало: 12.01.2026 Край: 30.06.2027 Възраст: от 18 г. Лечение

Australia, China Vibrant Sciences Limited NCT07222969

Набира участници Фаза 1

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults

Healthy Participants Healthy Adult Females Healthy Adult Male Healthy +1

This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 48 participants are planned to be randomized into 6 cohorts. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.

Начало: 12.01.2026 Край: 01.12.2026 Възраст: 18–55 г. Друго

Australia Dragonfly Therapeutics NCT07232121

Набира участници Фаза 1

ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants

Metabolic Dysfunction-Associated Steatohepatitis

This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.

Начало: 10.01.2026 Край: 01.05.2026 Възраст: 18–65 г. Лечение

Australia Eccogene NCT07334080

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