A Multi-Center Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients with Suspected Clonal Mast Cell Disease

Date Added
April 15th, 2026
PRO Number
Pro00149043
Researcher
Alexander Coltoff

List of Studies

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

This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.

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

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination with Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination with Darolutamide Versus Darolutamide Alone in Patients with Metastatic Hormone Sensitive Prostate Cancer

Date Added
April 17th, 2026
PRO Number
Pro00147949
Researcher
Kevin Becker

List of Studies

Keywords
Cancer, Men's Health, Prostate
Summary

This study is for patients who have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).This study is testing an investigational drug called Tulmimetostat, which will be given in combination with standard prostate cancer treatments: Darolutamide or Abiraterone. "Investigational" means that Tulmimetostat has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the safety and potential benefits of Tulmimetostat when given with Darolutamide or Abiraterone. The study will also evaluate whether adding Tulmimetostat can delay the progression of prostate cancer compared to treatment with Darolutamide alone. Participants will receive the study drug by mouth, along with standard androgen deprivation therapy (ADT). Those receiving abiraterone will also take a low-dose corticosteroid (prednisone or prednisolone) to help prevent side effects. Participants can expect to be in the study as long as they are benefiting from treatment or until the study ends. During the first 4 weeks, study visits will occur on Days 1, 2, 8, 15, and 22. Beginning with Cycle 2, participants will have visits on Day 1 of every 4-week cycle. At study visits, participants will undergo health assessments such as physical exams, blood and urine tests, heart monitoring (ECG), imaging scans (CT or MRI), and health questionnaires. Some participants may also have an optional biopsy. A total of 8 patients will be enrolled locally over the course of 32 months.

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

A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)

Date Added
April 22nd, 2026
PRO Number
Pro00147284
Researcher
Stephen Savage

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).

The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.

TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.

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

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Date Added
April 22nd, 2026
PRO Number
Pro00149814
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System
Summary

This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active CD. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active CD due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 1092 participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).

Institution
MUSC
Recruitment Contact
Sydney Britton
(843) 792-1425
brittosy@musc.edu

Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults with Alcohol Use Disorder

Date Added
May 5th, 2026
PRO Number
Pro00149840
Researcher
Lindsay Squeglia

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This study is testing whether an investigational compound called oleoylethanolamide (OEA) may help reduce alcohol use in young adults with alcohol use disorder. Young adults ages 18-25 will be randomly assigned to receive either OEA (250mg per day) or a placebo for six weeks. Researchers will measure alcohol use, immune function, oral bacteria, and thinking and decision-making. Compensation is available for those who qualify.

Institution
MUSC
Recruitment Contact
Brittney Browning
843-608-0514
Brownibr@musc.edu

Neural and Behavioral Dynamics During Neurorehabilitation

Date Added
May 7th, 2026
PRO Number
Pro00149437
Researcher
Nathan Rowland

List of Studies


Keywords
Brain, Physical Therapy, Spinal Cord, Stroke, Stroke Recovery
Summary

This research study aims to better understand how the brain and body change during physical or occupational therapy after a neurologic injury or condition. Adults who are already receiving outpatient neurorehabilitation will be invited to participate while they complete their regular therapy sessions. During therapy, participants will wear a lightweight cap that measures brain activity and will be video recorded so researchers can analyze movement patterns using computer software. These recordings do not change therapy activities and are for research purposes only. The study does not involve new treatments, medications, or procedures beyond standard care. Information collected may help researchers understand why recovery differs between individuals and improve future rehabilitation approaches.

Institution
MUSC
Recruitment Contact
M S Zobaer
832-955-7191
zobaer@musc.edu

LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer

Date Added
May 8th, 2026
PRO Number
Pro00149650
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer/Breast, Mental Health, Stage IV
Summary

LiveWell mBC is a group-based skills training program for women with metastatic breast cancer (mBC). The program teaches skills from dialectical behavioral therapy, an evidence-based psychotherapy, that have been adapted specifically to help women live as well as possible, with metastatic breast cancer. LiveWell mBC involves meeting with a small group of women with mBC plus two skills trainers 9 times total via telemedicine. Meetings include orientation plus 8 sessions learning and practicing skills including mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness and they last 90 minutes each. We are interested in seeing whether the program can help women to balance their emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with mBC.

Participants will be randomly assigned to one of two groups. They will have a 2 in 3 chance of being assigned to LiveWell mBC (experimental group) and a 1 in 3 chance of being assigned to Usual Care (control group). Women in the usual care group will continue to receive their standard oncology care. Participants in both groups will complete questionnaires four times total. Participants may be invited to participate in an exit interview about their experience. Participants will be compensated for completing questionnaires and the interview. For most people, participation will last approximately 4 months.

Institution
MUSC
Recruitment Contact
Kathryn Moody
843-792-9698
moodykat@musc.edu

Parent-Teen Conversations About Alcohol and Marijuana

Date Added
May 12th, 2026
PRO Number
Pro00149625
Researcher
Estephan Hakim

List of Studies

Keywords
Substance Use
Summary

This study examines how parents and adolescents communicate about alcohol and marijuana during mid-to-late adolescence, a period marked by rising substance use risk. Although many parents want to reduce harm, they often receive unclear guidance, and what parents intend to convey may not align with what adolescents perceive. Building on prior work showing that alcohol-specific communication is multidimensional and meaningfully linked to youth drinking outcomes, this study surveys parent–adolescent dyads (ages 15–18) to assess the content, frequency, and perception of substance-related conversations. The study also extends prior research by directly comparing parent and youth reports to identify alignment and discrepancies in communication. In addition, it addresses a major gap by characterizing marijuana-specific parental communication, which remains understudied despite increasing adolescent use. Finally, the study tests whether parents' trauma histories, particularly trauma involving substance use, shape how and what parents communicate to their children about alcohol and marijuana.

Institution
MUSC
Recruitment Contact
Estephan Hakim
(205) 616-4698
hakim@musc.edu

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Date Added
May 13th, 2026
PRO Number
Pro00148336
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for locally advanced/metastatic colorectal cancer. This study seeks to see if Fruquintinib in combination with TAS-102 improves overall survival when compared to Fruquintinib alone.The goal is to determine the optimal dose level, safety, and tolerability for the study drug.Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include high blood pressure, diarrhea, vomiting, reduced appetite, weight loss, hoarse voice, joint pain, and weakness. You 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

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 for the Treatment of Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD).

Date Added
May 15th, 2026
PRO Number
Pro00146615
Researcher
Stephen Stripling

List of Studies

Keywords
ADD/ADHD, Children's Health
Summary

Study 812P310 is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812.

All subjects who complete a blinded study of SPN-812 will have the option to participate in the OLE study in which all subjects receive SPN-812 (Study Medication, SM). Starting dose, dose range, and dose adjustments are all based on which double blind study the subject completed and, if applicable, the current age of the subject (Table 1). A subject who completed Study 812P202, 812P301 or 812P303, enters this OLE study at age 11 years, and then turns 12 while still in the study, their upper potential dose limit will then be raised from 400 mg to 600 mg and titration may occur at either 100 or 200 mg/week, as specified for the 12-17 year-old age group.

Institution
MUSC
Recruitment Contact
Sydney Horton
843.473.6616
syh206@musc.edu



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