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NCT03157128
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
NCT05417971
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
NCT07100080
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
NCT05580562
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
NCT05512949
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive. At least 210 participants will be enrolled and randomized to one of three study arms. The two dose sparing strategies include one-fifth (2 x 10\^7) and one-tenth (1 x 10\^7) of the standard dose of MVA-BN administered ID on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose standard (1 x 10\^8) MVA-BN SC regimen. The study will enroll a 1:1:1 randomization allocation. Participants will not be stratified by clinical trial site, demographic characteristics or human immunodeficiency virus (HIV) infection status; however, these data will be collected during screening and enrollment. Each participant may be screened either in a separate visit in the 7 days prior to Day 1 or on Day 1. The primary hypothesis involves a two-step hierarchical process. The study will first test non-inferiority of the 2 x 10\^7 ID regimen relative to 1 x 10\^8 SC (standard dose regimen). If the 2 x 10\^7 ID regimen is non-inferior to the standard dose regimen, hypothesis testing will proceed to test non-inferiority of the 1 x 10\^7 ID regimen relative to the standard dose regimen. The primary objectives are: 1) to determine if peak humoral immune responses following an ID regimen of 2 x 10\^7 50% Tissue Culture Infectious Dose (TCID50) MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC; 2) to determine if peak humoral immune responses following an ID regimen of 1 x 10\^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC.
NCT06903065
The purpose of this study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and activity of RO7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.
NCT02934568
This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.
NCT05518149
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).
NCT06082960
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
NCT06538636
Lung cancer is responsible for more deaths in the United States than breast, prostate and colon cancer combined and is the number one cancer killer of Veterans. This is because lung cancer is usually diagnosed when the disease has spread, and cure is less likely. Lung cancer screening (LCS) finds cancer at an earlier stage when it is curable, yet only 20% of eligible Veterans have been screened. Uptake is even lower among Black Veterans despite higher lung cancer risk. Using prediction models to identify high-benefit people for whom LCS should be encouraged improves efficiency and reduces disparities. Moreover, it is more patient-centered as shared decision-making conversations can be tailored with personalized information. The US Preventive Services Task Force has called for research to demonstrate that prediction-augmented LCS can be feasibly implemented at the point-of-care. The investigators propose for VA to lead this effort with a large-scale pragmatic clinical trial to show that prediction-augmented LCS is both feasible and improves LCS uptake.
NCT06383611
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives.
NCT04905069
To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
NCT05540327
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).
NCT06840483
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).
NCT07198087
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
NCT07395258
This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time. This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week. Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.
NCT05957367
This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.
NCT03618550
The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.
NCT06721689
The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.
NCT07229313
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.