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Found 14 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and initial effectiveness of T3011, a herpesvirus injection, combined with PD-1/PD-L1 inhibitors in adults with advanced solid tumors. This phase Ib/IIa clinical trial focuses on patients who have measurable tumors and a good performance status, aiming to understand how well this combination treatment is tolerated and how it impacts tumor response. Participants receive T3011 through injections directly into the tumor every two weeks. Alongside this, PD-1/PD-L1 inhibitors are given by intravenous infusion at a dose of 3 mg/kg every two weeks. The study includes high, middle, and low doses of T3011 to monitor different effects. This multi-center, single-arm trial does not include a comparison group and spans roughly two years. Throughout the study, researchers will monitor treatment-emergent side effects and measure how tumors respond to the therapy over about two years. Participants will undergo regular laboratory tests and pregnancy tests for women of childbearing potential. Safety assessments, including monitoring for adverse events and overall treatment tolerability, will be conducted. The study requires participants to comply with all procedures and follow-up visits during this period.

Age: 18Years +All GendersPhase 1Phase 2
22 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of Pimicotinib (ABSK021) combined with chemotherapy, with or without Toripalimab, in patients with advanced pancreatic cancer. This phase II, open-label study focuses on patients with non-resectable locally advanced or metastatic pancreatic cancer. The goal is to better understand how well this treatment works and how safe it is for this patient group. Participants will receive Pimicotinib orally once daily. Chemotherapy drugs Gemcitabine and nab-Paclitaxel will be given through intravenous infusion on days 1 and 8 of each 21-day cycle. Toripalimab, if used, will be administered intravenously on day 1 of each cycle. Treatment lasts about 24 weeks in different parts of the study, including Part A, Part B, and Part 2, depending on the group. During the study, participants will undergo safety monitoring from the day they sign consent until 90 days after finishing eight cycles of treatment. Effectiveness will be measured by the tumor response rate during the first eight cycles. Researchers will also perform various tests and assessments as outlined in the study protocol, ensuring close observation of how patients respond to the treatments and any side effects that occur.

Age: 18Years - 75YearsAll GendersPhase 2
5 locations
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Actively Recruiting

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Age: 18Years +All GendersPhase 3
1264 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of a new eye drop called 0.1% STN1013800 ophthalmic solution in Chinese patients who have acquired blepharoptosis, a condition where the upper eyelid droops. This Phase III study addresses the lack of approved medications for this condition in China by comparing the investigational drug to a placebo. The trial aims to determine whether the treatment improves eyelid function and vision-related outcomes. Participants receive either the STN1013800 ophthalmic solution or a placebo liquid base without the active ingredient once daily for 42 days. Before starting treatment, there is a screening period lasting 3 to 7 days to confirm eligibility. The dosing and administration schedule follows previous clinical trial results, focusing on consistent daily application. During the study, participants undergo assessments including visual field tests and measurements of eyelid position at specific times on Day 1 and Day 14. Researchers monitor changes from baseline in these measures to evaluate treatment effects. Safety and adherence are observed throughout the 42-day treatment period to ensure participant well-being and reliable study results.

Age: 18Years - 75YearsAll GendersPhase 3
21 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of a combination treatment using selinexor, azacitidine, and venetoclax for adults newly diagnosed with acute myeloid leukemia (AML) who have not received prior treatment. This Phase 2, prospective, single-arm, multi-center clinical trial aims to understand how well this combination works specifically for patients who are either not suitable for intensive chemotherapy or who refuse it. The study focuses on measuring the percentage of participants who achieve complete remission from the start of the study up to about two years or until death. The treatment regimen involves giving selinexor orally at 60 mg on days 3, 10, and 17; azacitidine intravenously at 75 mg/m2 on days 1-3, 8-9, and 15-16; and venetoclax orally starting with 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14. Each cycle lasts 28 days. Participants may proceed to receive a transplant at any time after achieving complete remission. Those who do not undergo transplant will continue treatment until their disease worsens or side effects become unacceptable. During the study, participants will be closely monitored through various evaluations to assess treatment response and safety. Researchers will track remission status, disease progression, and any adverse effects. The total study period involves treatment cycles and follow-up lasting up to approximately two years. This ongoing monitoring helps determine the overall benefit and risks of the combination therapy for AML patients who are treatment naive.

Age: 18Years +All GendersPhase 2
19 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in women with recurrent or metastatic cervical cancer. This Phase II, multicenter, open-label, randomized study focuses on participants who have previously received at least one systemic therapy. The goal is to understand how these treatments impact progression-free survival over three years. The study involves two treatment groups: one receiving GT101 injection, a biological therapy derived from the patient's own tumor cells, and the other receiving Gemcitabine injection, a chemotherapy drug. Participants will be randomly assigned to either group and treated according to the study protocol. The study is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will be monitored regularly for treatment effects and safety. Assessments will include measuring tumor response using standard criteria and evaluating overall health status. Researchers will track progression-free survival for up to three years. The study requires female participants aged 18 to 70 with specific health and disease criteria, and they must provide informed consent before joining.

Age: 18Years - 70YearsFEMALEPhase 2
24 locations
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Actively Recruiting

Researchers are investigating the effectiveness and safety of a sublingual immunotherapy called MM09 for treating people aged 12 to 65 with moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by house dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae). The study also includes participants with or without mild-to-moderate controlled asthma. This phase III, randomized, double-blind, placebo-controlled trial aims to see if MM09 can reduce symptoms and the need for rescue medication compared to a placebo. Participants receive a sublingual spray of MM09 at a dose of 30,000 TU/mL or a placebo for 12 months. The treatment is given daily under the tongue. The trial is conducted at multiple centers and includes careful monitoring of participants throughout the treatment period. Researchers will observe participants for any medical problems that occur when inhaling MM09 and compare results with those receiving the placebo. During the study, participants will use a smartphone to record their symptoms and medication use. Researchers will assess the combined symptom and medication score during the last four weeks of treatment to evaluate effectiveness. Safety assessments and monitoring for adverse effects will also be conducted. The total duration of participation includes the 12-month treatment period with ongoing evaluations to understand MM09's impact on allergic rhinitis, rhinoconjunctivitis, and asthma symptoms.

Age: 12Years - 65YearsAll GendersPhase 3
19 locations
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Actively Recruiting

Acute myocardial infarction (AMI), especially ST-segment elevation myocardial infarction (STEMI), is a major cause of death worldwide. Despite advances in reperfusion therapies like primary percutaneous coronary intervention (pPCI), mortality rates remain high, and many survivors develop heart failure. This research focuses on a new mechanism involving leukotriene C4 (LTC4) that worsens heart injury after STEMI, and explores how blocking LTC4 receptors with montelukast could improve heart recovery and reduce complications. Participants will receive either montelukast or a placebo at a dose of 10 mg daily for three months following enrollment. The study targets patients with anterior STEMI undergoing pPCI within 12 hours of symptom onset. Montelukast is being tested for its ability to reduce myocardial ischemia-reperfusion injury by blocking LTC4 receptors, potentially improving heart function and remodeling after the heart attack. During the 24-week study, researchers will monitor changes in left ventricular remodeling as the primary outcome. Participants will undergo evaluations including cardiac magnetic resonance imaging and clinical assessments to track heart function and injury recovery. Safety and effectiveness will be carefully observed throughout the treatment period, offering insight into montelukast's potential as a cardiac protective therapy for STEMI patients.

Age: 18Years - 75YearsAll GendersPhase 3
12 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of eldecalcitol compared to calcitriol in postmenopausal women who have low bone mineral density (BMD) or mild osteoporosis. This randomized, open-label, phase 4 trial focuses on women aged 50 years or older who have been postmenopausal for more than 2 years or are at least 60 years old if menopausal status is uncertain. The study aims to provide insights into treatments that may help manage bone health in this population. Participants will be randomly assigned in equal numbers to receive either oral eldecalcitol capsules at a dose of 0.75 micrograms daily or oral calcitriol capsules at a dose of 0.5 micrograms daily. The treatment period lasts for 12 months, with both medications taken openly without blinding. This comparison will help assess the differences between these two therapies for bone density improvement. Throughout the study, participants will undergo evaluations including bone mineral density measurements at the lumbar spine using DXA scans, with the primary outcome focusing on percent change from baseline to month 12. Safety assessments, monitoring of calcium levels, and review for any adverse events will be conducted. Participants are expected to be ambulatory outpatients and will provide written informed consent. The total study duration for each participant is 12 months of treatment.

Age: 50Years +FEMALEPhase 4
21 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of a chemotherapy drug called JSKN003 compared to other chemotherapy treatments chosen by doctors for adults with HER2-low, unresectable, or metastatic breast cancer. This study focuses on patients whose cancer has returned or spread and who have already tried one or two previous chemotherapy treatments without success. It is a phase III, open-label, randomized study conducted at multiple centers. Participants will be randomly assigned to one of two groups: one group will receive JSKN003 given through an intravenous infusion according to the study plan, while the other group will receive one of several chemotherapy drugs selected by their doctor before joining the study. These options include capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. Treatment is given as a single drug in both groups. During the study, participants will be monitored for up to about three years to see how long they live without their cancer worsening. Researchers will conduct imaging scans, lab tests, and other evaluations to track disease progression and overall health. Safety and side effects will be carefully observed, and participants' tumor samples will be analyzed to confirm HER2 status. The study aims to enroll 408 subjects and includes follow-up assessments to ensure continued monitoring of treatment outcomes.

Age: 18Years +All GendersPhase 3
87 locations

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