A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer

Date Added
September 12th, 2023
PRO Number
Pro00128530
Researcher
Mariam Alexander

List of Studies

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

The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.

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

A Phase Ib, Open Label, Multicenter Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination with 2X-121 in Patients with Advanced Solid Tumors

Date Added
September 12th, 2023
PRO Number
Pro00127917
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This is a clinical research study that is using an investigational product, 2X-121, as a possible treatment for diagnosed advanced solid tumors, both alone and in combination with another investigational product, dovitinib. Both drugs are taken orally and are also investigational, meaning that the FDA (the U.S. Food and Drug Administration) has not yet approved them as a treatment for any disease. The results of this study and previous studies will be used to design future studies to improve treatment of advanced solid tumors. This study will help determine the safety of 2X-121 and dovitinib. The study will help determine a safe and effective dose of 2X-121 alone and a safe and effective dose of dovitinib when given in combination with 2X-121. Subjects participating in this study will contribute to the development of a drug which has the potential to become a treatment option for them and others in the future. The expected duration of the study for participants is 24 months, this research study will involve two parts. Participants in Part 1 will be assigned to receive either 600 mg, 800 mg, or 1000 mg of 2X-121 daily for 28 days. Participants in Part 2 will be assigned to receive the chosen daily dose of 2X-121 as decided after Part 1, along with dovitinib at either a 300 mg, 400 mg, or 500 mg dose once daily for five days followed by 2 days without dovitinib. The 5 days on / 2 days off schedule will repeat for 28 days. Some reasonably foreseeable risks and discomforts include: Fatigue, Urine discoloration, diarrhea, nausea, vomiting, decreased appetite, rashes. It is hoped that the information gained from the study will help in the treatment of future patients with conditions like yours.

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

A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy.

Date Added
September 12th, 2023
PRO Number
Pro00128912
Researcher
Josef Eichinger

List of Studies


Keywords
Drug Studies, Joint, Muscle, Pain
Summary

Patients greater than/equal to 18 years of age who are diagnosed with unilateral rotator cuff tendinopathy (with MRI confirmation) will be recruited. The purpose of the study is to measure the safety and efficacy of the drug secukinumab, 300mg s.c. (subcutaneous) compared to placebo. The use of secukinumab for the treatment of tendinopathy is investigational in this study, but FDA approved for other indications. The study will be a randomized, double-blind study. This means the participant, nor the researchers will know if the drug or placebo is administered. The treatment period will last 16 weeks, during which the patient will receive 7 doses of the study drug (2 injections per dose) over 12 weeks. Participants will continue follow-up until week 24. A total of 11 visits are required for the study, each will take approximately 3 hours to complete. These visits will be at the following timepoints: Screening visit, Baseline visit, and visits at weeks 1,2,3,4,8,12,16, 20, and the end of the study visit. The location of the injection will be the affected shoulder.

Risks include but are not limited to upper respiratory tract infections, with symptoms such as sore throat and stuffy nose. Common risks include Cold sores, Athletes foot, runny nose, diarrhea, itchy rash (urticaria). Rare and serious risks include Severe allergic reaction with shock (anaphylactic reactions). A blood draw may cause fainting, pain, and/or bruising, dizziness, and in rare cases, infection.

Institution
MUSC
Recruitment Contact
Maggie Schiessl
843-792-7534
schiessl@musc.edu

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date Added
September 12th, 2023
PRO Number
Pro00131432
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for patients with obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body.

The study is done to compare the side effects and effectiveness of an investigational (not yet approved by the Food and Drug Administration (FDA)) medication with the beta-blocker metoprolol succinate in participants with oHCM. The study medication is known as Aficamten and is a tablet taken by mouth. This is a randomized study (participants will be assigned by chance to the study medication Aficamten and placebo or metoprolol succinate and placebo). A placebo looks just like the study medication but has no active ingredient in it. The medications will be administered in the form of a pill. This study will take about 9 months and include about 11 visits to the study site. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), exercise testing, physical exams, questionnaires and optional genetic testing. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Date Added
September 13th, 2023
PRO Number
Pro00130566
Researcher
Mariam Alexander

List of Studies

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

The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.

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

Informed Choice Intervention for Colorectal Cancer Screening: COMPASS

Date Added
September 14th, 2023
PRO Number
Pro00127491
Researcher
Gary Headden

List of Studies


Keywords
Cancer
Summary

The purpose of this research study is to see the impact of a study video on CRC screening rates and adherence.

Approximately 5,280 subjects will participate in this study at roughly 40 sites.

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

The impact of cannabis and tobacco/nicotine product co-use in young adults: Prospective cessation evaluation and substitution

Date Added
September 15th, 2023
PRO Number
Pro00131124
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Institution
MUSC
Recruitment Contact
Emma Mandel
843-792-4097 or 843-830-0165
smokingstudy@musc.edu

Identification of Facilitators and Barriers for the Management of Pediatric Asthma within School-based Clinics: A Mixed Methods Approach

Date Added
September 16th, 2023
PRO Number
Pro00130502
Researcher
Katherine Chike-Harris

List of Studies


Keywords
Asthma, Pediatrics
Summary

Pediatric asthma is not well controlled in SC and it's important to understand the facilitators and barriers to asthma care, especially in rural and underserved populations. Though school-based clinics provide quality asthma care to pediatric patients and has been shown to increase asthma control and decreased unnecessary health care utilization (i.e., emergency room), enrollment continues to be low. To identify and understand the facilitators and barriers to asthma care within school-based clinics, it is important to query caregivers (parents, grandparents, foster parents, legal guardians) and providers (doctors, APPs) to elicit their thoughts and opinions. This study will include caregiver and provider surveys and individual interviews to collect and analyze these thoughts and opinions.

Institution
MUSC
Recruitment Contact
Katherine Chike-Harris
843-792-4649
chikehar@musc.edu

Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes

Date Added
September 19th, 2023
PRO Number
Pro00130184
Researcher
Amanda Palmer

List of Studies

Keywords
Smoking
Summary

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

Institution
MUSC
Recruitment Contact
Rachel Christian
(843) 737-1516
chrisrac@musc.edu

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

Date Added
September 26th, 2023
PRO Number
Pro00131740
Researcher
Chirantan Banerjee

List of Studies


Keywords
Stroke
Summary

The purpose of this study is to investigate the efficacy of the oral FXIa inhibitor asundexian in prevention of ischemic stroke and its safety (bleeding) compared with placebo on top of background antiplatelet therapy in adult participants after an acute non-cardioembolic ischemic stroke or high-risk TIA.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
(843) 792-8606
lemattyc@musc.edu



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