A Phase I/Randomized Phase II, Open-Label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients with Pancreatic Adenocarcinoma

Date Added
August 13th, 2024
PRO Number
Pro00134872
Researcher
Albert Lockhart

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 pancreatic adenocarcinoma following surgery in order to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BNT321 in combination with mFOLFIRINOX. BNT321 is not FDA approved. mFOLFIRINOX is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, headache, fever, and joint pain. 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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Date Added
August 13th, 2024
PRO Number
Pro00138400
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study involves an investigational drug called ALXN2220 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Investigational means it is not yet approved for commercial use or sale by the Food and Drug Administration (FDA). ALXN2220 is intended to promote the elimination of ATTR deposits leading to symptom improvement.
All participants will be randomized, meaning assigned by chance, to receive ALXN2220 or placebo. A placebo looks like the study drug but contains no active medication. In this study, participants will have a 2 out of 3 chance, like drawing straws, of receiving the study drug and 1 out of 3 chance of receiving placebo. Neither the participants nor the study team or study doctor will know if they are assigned to receive the study drug or placebo. The study drug or placebo will be administered intravenously (IV), meaning into a vein in the arm, every four weeks.
Participation in this study will include a maximum of 56 visits over a maximum of 48 months. Study procedures include collection of vital signs, study drug infusion, physical exams, 12-lead electrocardiography, blood and urine collection, echocardiogram (ultrasound test of the heart), questionnaires, and some optional testing.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

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

The Effects of Adolescents Alcohol Use on Oral Microbiota and the Brain.

Date Added
August 6th, 2024
PRO Number
Pro00138324
Researcher
Anna Kirkland

List of Studies

Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.

Institution
MUSC
Recruitment Contact
Anna Kirkland
(843) 792-5453
kirklaan@musc.edu

A Phase 1 Study of NM32-2668 (Anti-ROR1/Anti-CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients with Selected Advanced Solid Tumors

Date Added
August 6th, 2024
PRO Number
Pro00136728
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Drug Studies
Summary

The present study is a first-in-human, non-randomized, open-label, multi-center, Phase 1 trial with NM32-2668 in selected advanced solid tumors that represent a group of indications most likely to overexpress ROR1. The key purpose of the trial is to determine the maximum tolerated dose (MTD) sequence and/or therecommended Phase 2 dose (RP2D) sequence of NM32-2668 monotherapy. Up to 15 sites in the United States, Canada, and Spain (Part I and Part II, Dose
Escalation) Up to 40 sites in the United States, Canada, and EU (Part III, Dose Expansion) Part I and Part II (Dose Escalation): approximately 36 months Part III (Dose Expansion): approximately 18 months.

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

An Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension – ASCENT Study

Date Added
July 17th, 2024
PRO Number
Pro00136738
Researcher
Rachana Krishna

List of Studies


Keywords
Drug Studies, Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2 Study of Alisertib in Patients with Extensive Stage Small Cell Lung Cancer

Date Added
July 11th, 2024
PRO Number
Pro00135995
Researcher
Christopher Rangel

List of Studies

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

In this study, researchers are testing a drug called Alisertib in people with a specific type of lung cancer that has spread extensively. These patients have already undergone the first round of treatment, but unfortunately, their cancer has started growing again. The drug alisertib works by targeting certain molecules involved in cell division, which are often overactive in cancer cells.

Patients will take alisertib as pills twice a day for a week, followed by a break. To manage side effects, they'll also receive another medication to support their blood cell production. Throughout the study, researchers will closely monitor how much alisertib is in the patients' blood and how they're responding to treatment.

The study will continue until patients either see their cancer progress, experience intolerable side effects, or decide to leave the study. Even if the cancer spreads to the brain during the study, patients might still be able to continue treatment if it's deemed helpful by their doctor. This research hopes to find out if alisertib can offer a new option for people whose lung cancer has come back after initial treatment.

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

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Date Added
June 24th, 2024
PRO Number
Pro00134737
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver
Summary

The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

A Phase II Study of Fingolimod in Patients with Non-Small Cell and Small Cell Lung Cancer

Date Added
June 18th, 2024
PRO Number
Pro00137404
Researcher
Mariam Alexander

List of Studies

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

This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.

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



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