BCC021- Phase I/II Study of Silmitasertib (CX-4945) in Combination with Chemotherapy in Children and Young Adults with Relapsed Refractory Solid Tumors

Date Added
May 27th, 2026
PRO Number
Pro00146904
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Pediatrics, Women's Health
Summary

This study is testing a drug called silmitasertib to see if it is safe and works well when used with chemotherapy in children and young adults whose solid tumors have come back or didn't respond to treatment. In the first part of the study (Phase I), doctors will check how safe the drug is and what side effects it may cause. They will use a dose that is already recommended for adults and may try a slightly higher dose. Patients will take silmitasertib twice a day for 21 days along with chemotherapy. Doctors will then see if this treatment plan is safe and doable. In the second part (Phase II), the study will focus on two types of cancer: neuroblastoma and Ewing sarcoma. It will test how well silmitasertib works with chemotherapy for these cancers. The main goal is to see how many patients respond to the treatment. Other goals include seeing how long patients live without their cancer getting worse and how long they live overall. The study will include up to 104 patients across the country, including 2 at MUSC. The main risk is side effects. The most common ones expected are stomach problems, tiredness, low red blood cell count (anemia), and loss of appetite. There is no direct benefit for patients who join this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

Enhancing Virtual Mindfulness Program to Improve Physical Activity in Adults With Pulmonary Hypertension: Usability Optimization, Feasibility Testing, and Implementation Strategy Development

Date Added
May 21st, 2026
PRO Number
Pro00150536
Researcher
Tania Von Visger

List of Studies

Keywords
Pulmonary Hypertension
Summary

The purpose of this pilot study is to refine a mobile app, based on usability data, from 15 adults living with pulmonary hypertension (PH). The app is intended to reduce symptom burden and improve health-related quality of life for adults with PH, a chronic and debilitating cardiopulmonary condition. Participants will be asked to use the app and provide their thoughts about how to make it better by completing surveys and through interview. We also aim to assess readiness for broader implementation through surveys and targeted interviews with PH providers (N=15). Optimizing barriers and facilitators to implementation and gathering clinician perspectives will inform the design of a future randomized controlled feasibility trial.

Institution
MUSC
Recruitment Contact
Tania Von Visger
614-822-6637
vonvisge@musc.edu

Studying the Presence of CFRD Complications with Thoughtful Recruitment (SPeCTRuM)

Date Added
May 21st, 2026
PRO Number
Pro00149877
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Diabetes
Summary

This observational study will systematically pursue ADA (American Diabetes Association)
recommended screening for diabetic microvascular complications and macrovascular surrogates in patients with CFRD (Cystic Fibrosis Related Diabetes). The study will enroll approximately 200 subjects, each of which will participate for 4 weeks. Each subject will be asked to fill in questionnaires related to their complications.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437926109
recruitment@musc.edu

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

Date Added
May 21st, 2026
PRO Number
Pro00148409
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for people with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C gene mutation. The study is testing a drug called BBO-8520. This drug is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The drug will be tested by itself or together with another drug called pembrolizumab (also called "pembro"). People who have not taken a KRAS G12C inhibitor before and are in the Dose Expansion part of the study (Phase 1b) will be randomly assigned (like flipping a coin) to get one of two doses chosen by the study review committee (SRC). These doses are based on information from the earlier Dose Escalation part (Phase 1a). People who have taken a KRAS G12C inhibitor before may also be randomly assigned to one of two doses, but only after a first group of participants gets a set dose recommended by the SRC.

During the study, all participants will take BBO-8520 by mouth once or twice a day. If you are getting BBO-8520 with pembrolizumab, you will get pembrolizumab every 21 days. Pembrolizumab will be given through an IV about 30 minutes after you take BBO-8520. Pembrolizumab will continue until your cancer gets worse, you have side effects that are too severe, you choose to stop, or for up to 24 months—whichever happens first.
The whole study is expected to last about 5 years if the cancer does not get worse.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Date Added
May 19th, 2026
PRO Number
Pro00151048
Researcher
Andrea Abbott

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.

A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.

Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.

Risks include infection, scarring, and bleeding. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Study of Acute Alcohol Binge-Induced Gut Barrier Dysfunction and Upregulation of CYP2E1

Date Added
May 19th, 2026
PRO Number
Pro00150802
Researcher
Garth Swanson

List of Studies

Keywords
Alcohol, Liver, Stomach
Summary

A single weight based dose of alcohol will be given to approximate an alcohol binge (aiming to achieve a blood alcohol concentration of approximately 0.08%) to investigate downstream effects on intestinal permeability and changes in hepatic steatosis. Several studies have been performed in humans under similar conditions and looking at similar things. The PI, Dr. Garth Swanson, conducted one of these studies previously. Here, participants will be given a weight-based dose (2mL vodka per kg body weight) of alcohol, with assessment of intestinal permeability via urine collection over the 24 hours directly following alcohol consumption, assessment of changes in hepatic steatosis by evaluation with fibroscan before and after alcohol consumption, and blood markers of endotoxemia and related inflammatory markers after. The weight-based dosing of alcohol was chosen to reflect previous studies looking at the effects of a single episode of alcohol binge use, with the goal of achieving a blood alcohol concentration of approximately 0.08%, the lower limit of what is needed to be considered an acute alcohol binge.

Institution
MUSC
Recruitment Contact
Keaveny (Katy) Donovan
8437927974
donova@musc.edu

Home-Based Neuromuscular Electrical Stimulation for Muscle Preservation in Amyotrophic Lateral Sclerosis: A Pilot Contralateral Sham-Controlled Feasibility Study

Date Added
May 19th, 2026
PRO Number
Pro00150221
Researcher
Sarah Breevoort

List of Studies

Keywords
Nerve
Summary

The purpose of this study is to evaluate whether neuromuscular electrical stimulation (NMES) can help preserve muscle strength and muscle thickness in individuals living with amyotrophic lateral sclerosis (ALS). ALS is a progressive disease that causes weakness and muscle loss over time. NMES is a therapy that uses small electrical impulses delivered through adhesive pads placed on the skin to stimulate muscles to contract.
Participants in this study will use a portable NMES device at home approximately three times per week for 12 weeks. One muscle group will receive active electrical stimulation while the same muscle group on the opposite side of the body will receive low-intensity stimulation that does not produce a visible muscle contraction. This allows researchers to compare the effects of stimulation within the same participant.
During the study, participants will attend periodic clinic visits where researchers will measure muscle strength, evaluate muscle thickness using ultrasound, and ask questions about symptoms such as fatigue, muscle cramps, and comfort with the device. A follow-up visit will occur four weeks after the stimulation period ends. The goal of this pilot study is to determine whether home-based NMES is safe, feasible, and acceptable for individuals with ALS and to gather preliminary information about whether it may help slow muscle decline.

Institution
MUSC
Recruitment Contact
Mikayla Allen
4172806993
allenmik@musc.edu

Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System (VENOS - 3)

Date Added
May 19th, 2026
PRO Number
Pro00149783
Researcher
John Aruny

List of Studies

Keywords
Kidney
Summary

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.

Institution
MUSC Health Orangeburg
Recruitment Contact
virginia anderson
803-395-3878
andersvi@musc.edu

MUSC Digestive Disease Research Core Center (DDRCC) Biorepository

Date Added
May 19th, 2026
PRO Number
Pro00149277
Researcher
Garth Swanson

List of Studies

Keywords
Bowel, Crohn's Disease, Digestive System, Hepatology, Inflammatory Bowel Disease, Liver, Non-interventional, Pancreas, Ulcerative colitis
Summary

The goal of the DDRCC Biorepository is to collect human samples and health information to store for future research. Samples to be collected are blood, tissue (gastrointestinal, liver, pancreas and/or lymph nodes), stool, and cheek swabs. Participants may be eligible to enroll if scheduled for a clinical visit or surgical procedure during which these samples could be collected.

Institution
MUSC
Recruitment Contact
Katie Tremont
843-876-6377
tremontk@musc.edu

Developing at-home taVNS for neurorehabilitation in Parkinson's Disease

Date Added
May 19th, 2026
PRO Number
Pro00149153
Researcher
Daniel Lench

List of Studies

Keywords
Parkinsons
Summary

This study is designed to explore a new treatment option for motor symptoms in people with Parkinson's disease. Motor symptoms and gait disturbance for Parkinson's are often disabling and can increase risk of falls and requce quality of life. We are testing whether a non-invasive brain stimulation technique called transcutaneous auricular vagus nerve stimulation (taVNS) is tolerable, acceptable and can be administered at-home and used to improve symptoms of Parkinson's disease. TaVNS delivers electrical impulses through the skin of the ear to the vagus nerve which research has shown modulates brain activity. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating the symptoms of Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.

Institution
MUSC
Recruitment Contact
Emily Laramie
8437923873
laramie@musc.edu



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