A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination With Nivolumab In Patients With Advanced Solid Tumors

Date Added
October 12th, 2021
PRO Number
Pro00114862
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with non-small cell lung cancer. The investigational drug in this study is Ozuriftamab Vedotin (BA3021). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Ozuriftamab Vedotin by intravenous (IV) infusion. The purpose of this study is to see how Ozuriftamab Vedotin alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe Ozuriftamab Vedotin is alone and in combination with nivolumab; to understand how the body absorbs and processes Ozuriftamab Vedotin; to understand whether Ozuriftamab Vedotin, alone or in combination with Nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase your risk of side effects. Participants can expect up to 75 clinic visits over a period of about 3 years.

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

A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Date Added
September 14th, 2021
PRO Number
Pro00113625
Researcher
Toros Dincman

List of Studies

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

This study is enrolling participants with advanced solid tumors. The purpose of the study is to see how safe the study drug Ginisortamab is and how the body processes the drug when given alone or in combination with selected standard of care (SOC) regimens. Participants will receive Ginisortamab via intravenous (IV; injected into a vein) infusion (drip) every 2 weeks, on Days 1 and Day 15 of each treatment cycle. If they continue to additional cycles, the infusions will continue to take place every 2 weeks according to the same schedule. Participants will be in this trial for a planned period of at least 2 cycles of study treatment (around 8 weeks) but should the Study Doctor decide that he/she is benefiting from treatment, he/she can remain in the study for additional cycles of treatment until he/she decide to withdraw from the study, he/she experiences any unacceptable side effects due to the treatment or if the disease worsens.

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

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Date Added
September 14th, 2021
PRO Number
Pro00110634
Researcher
Richard Silver

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

The purpose of this study is to test whether a drug called HZN-825 (the study drug) is an appropriate treatment for patients with Systemic Sclerosis (SSc). HZN-825 is an investigational drug that taken by mouth as a pill. An investigational drug is not approved by The US Food and Drug Administration and can only be used in a research study, like this one.

In this study, HZN-825 will be compared with a placebo (a pill that looks like the study pill but does not have any study drug in it). The comparison with the placebo helps to determine whether the effects seen in your body is because of HZN-825 or not. This is a randomized study meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. This will be done with the help of a computer-based program, and you will have 67% chance of receiving HZN-825. The study is double-blinded, meaning you and your study doctor will not know what you are receiving, the study drug or placebo. Should an emergency arise, and it is determined necessary, your study doctor will be able to find out what medication group you have been assigned.

The study is sponsored by Horizon Therapeutics Ireland DAC. The study is being done at approximately 135 sites across the world. The study is 60 weeks long will require 12 visits to the MUSC main campus. During study participation, the following procedures will be completed: blood draw, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High-Resolution Computed Tomography (HRCT)), electrocardiogram, as well as being asked to complete surveys about your overall health and wellbeing. Compensation is available for participation

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
frasibri@musc.edu

A multi-center phase Ib trial evaluating the safety and efficacy of lacutamab in patients with relapse peripheral T-cell lymphoma that express KIR3DL2

Date Added
August 24th, 2021
PRO Number
Pro00113053
Researcher
Irl Greenwell

List of Studies


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

This study is for subjects that have been diagnosed with peripheral T-cell lymphoma (PTCL) and have received at least one prior systemic therapy for their disease. This study is testing an "investigational" (not yet FDA approved drug) study drug called Lacutamab (IPH4102). The primary purpose of this study is to evaluate the safety and effectiveness of lacutamab. The subject may remain in the study until their disease progresses or they have developed unacceptable toxicity secondary to lacutamab and can expect to be in follow-up for 1 year if they discontinue treatment in the first year.

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

Long-Term Nicotine Treatment of Mild Cognitive Impairment

Date Added
August 3rd, 2021
PRO Number
Pro00112159
Researcher
Jacobo Mintzer

List of Studies


Keywords
Aging, Alzheimers, Brain, Dementia, Drug Studies, Memory Loss
Summary

The purpose of the study is to see if daily use of nicotine patches will slow or reverse memory loss in participants with Mild cognitive impairment, an early stage of mental decline associated with Alzheimer's disease. Nicotine may mimic natural chemicals in the brain that play a crucial role in memory function, and previous studies have shown that nicotine may improve attention, learning, and memory. In this study, participants will receive either nicotine (up to 21mg/day, the standard dosage of a nicotine patch) or placebo for 2 years to see if these improvements in brain function can be observed over a longer period.

Institution
MUSC
Recruitment Contact
Allison Lapp
843-608-1950 x 1109
allisonlapp@lcvresearch.org

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF-β Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called BCA101. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get BCA101 alone or BCA101 in combination with pembrolizumab. Participants will receive either BCA101 alone, BCA101 in combination with pembrolizumab or BCA101 and enforafenib, depending on your cancer until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu



-- OR --