The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
December 16th, 2021
PRO Number
Pro00115395
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is Buparlisib (AN2025) that will be given in combination with Paclitaxel (an approved drug). The study will also use alone.

The main purpose of this research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone head and neck cancer that has progressed after prior immunotherapy (treatment that uses your immune system to attack your cancer, such as antiPD1/antiPDL1 treatments) with or without prior platinum-based chemotherapy. Participants can expect to be on this study for about 5 years.

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

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Date Added
October 26th, 2021
PRO Number
Pro00114229
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 (NSCLC). The investigational drug in this study is sotorasib. Investigational means it is not approved by the United States Food and Drug Administration (US FDA). Sotorasib is an anti cancer drug that is being developed for tumors with a specific mutation called Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C. The purpose of this study is to find out if sotorasib has any anti-tumor effect and how safe (including side effects) it is in subjects with stage 4 NSCLC with a KRASG12C mutation. This drug is a tablet taken by mouth once a day. Participants can expect to receive treatment approximately 6 to 12 months including about 48 clinic visits followed by 5 years of follow-up.

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

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, a Phase I/II Trial

Date Added
October 19th, 2021
PRO Number
Pro00113440
Researcher
Michael Lilly

List of Studies


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

This study is for subjects that have been diagnosed with advanced solid cancer tumors or relapsed prostate cancer. The investigational drugs in this study are hydroxychloroquine, nelfinavir, metformin, dasatinib and sirolimus. The purpose of this study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of cancer. Subjects can expect to be in this study for about 2.5 years.

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

A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors

Date Added
October 18th, 2021
PRO Number
Pro00114515
Researcher
John Kaczmar

List of Studies


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

This study is for participants that have a solid tumor that hasn't responded to previous treatment or has spread to other parts of the body (metastatic), including ovarian, cervical, endometrial, head and neck, squamous cell lung, kidney, prostate, colorectal, gastric, breast, bladder cancer, lung adenocarcinoma, or melanoma. This research study is for the investigational drug called TTX-080. This drug has not been approved by the United States Food and Drug Administration (FDA). This purpose of this study is to see what effects TTX-080 has on tumors. TTX-080 may help the immune system attack cancer cells. The study drug is given intravenously (into the vein). It is expected that participants could be in the study for about 2 years and will depend on how he/she tolerate the study drug. Participants may experience certain side effects and discomforts from taking TTX-080. Because the study drug is experimental, all the side effects may not be known.

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

An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Date Added
October 12th, 2021
PRO Number
Pro00114829
Researcher
Daniel Judge

List of Studies


Keywords
Drug Studies, Heart
Summary

Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study will continue to evaluate the safety and tolerability of a new drug called acoramidis given to adult patients with symptomatic transthyretin amyloid cardiomyopathy. All participants will be given the study medication, which is taken by mouth twice a day.

This study is enrolling subjects who participated in the AG10 301 study, and are eligible to enroll in this study within 30 days of completing the 30 month visit for the AG10 301 study. This study is expected to last approximately 5 years and will have in person visits at day 1, month 1 and then every 6 months along with phone visits quarterly when an in person visit is not required.

Institution
MUSC
Recruitment Contact
Hannia Ramos
843-876-4806
ramosha@musc.edu

Safety and Efficacy of GEN3009 (DuoHexaBody® -CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts

Date Added
October 12th, 2021
PRO Number
Pro00113432
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 diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL) or follicular lymphoma (FL) for which they previously have received treatment, but the disease is worsening or has come back and no standard approved treatment options are available to them. This study is testing an "investigational" (not yet FDA- Food and Drug Administration- approved drug) study drug called GEN3009 (DuoHexaBody®-CD37). The purpose of one arm of the study is to find out if and how well the GEN3009 works against a subject's cancer (this is called the dose expansion part). The primary purpose of the second arm of the study is to determine the maximum tolerated dose (the highest dose of the drug that does not cause unacceptable side effects) with and/or determine the recommended dose of the study drug for the next phase of studies for this drug, as well as to evaluate the safety and tolerability of the study drug (this is called the dose escalation part). The subject may be seen up to once a week during this study. The subject may remain in the study for up to five years.

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

A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor

Date Added
October 12th, 2021
PRO Number
Pro00113721
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 metastatic Non-Small Cell Lung Cancer (NSCLC). The investigational drug in this study is BA3011. 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 BA3011 by intravenous (IV) infusion. The purpose of this study is to understand how BA3011 works with and without nivolumab in fighting cancer cells; to see what side effects BA3011 has when given alone and in combination with nivolumab; to understand how the body absorbs and processes BA3011; and to understand whether BA3011, 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). Participants can expect to be in this study for about 2 and a half years.

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

A Phase 1/2 Dose Escalation and Dose Expansion Study of 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 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 BA3021 by intravenous (IV) infusion. The purpose of this study is to see how BA3021 alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe BA3021 is alone and in combination with nivolumab; to understand how the body absorbs and processes BA3011; to understand whether BA3011, 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

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The RAPID Study (NODE-301 Part 2)

Date Added
September 28th, 2021
PRO Number
Pro00113657
Researcher
John Wharton

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is seeking participants with Paroxysmal Supraventricular Tachycardia (PSVT) which is a specific type of fast heart rhythm, to participate in a randomized study using an investigational (not yet approved for commercial use or sale by the US Food and Drug Administration (FDA) medication versus placebo (looks like medication but there is no active ingredient). The study medication, known as Etripamil, is a nasal spray. Participants will receive a test dose of the medication to see its effect, then be taught to give themselves the medication so the treatment can be done in a home setting. Participants will then be randomized (assigned by chance) to study medication vs placebo to use at home when an episode of PSVT occurs. Participants will also be shown how to place a heart monitor on their chests to record while using the study medication. Participation in this study will last approximately 12-18 months and will include at least 4 clinic visits including screening/test dose visit, randomization treatment, randomization treatment follow up and final study visit. In addition to these 4 visits you will also have a monthly study call or clinic visit to check in with you. Physical exams, vital signs, blood work, urinalysis, ECGs (recording of electrical activity of the heart), placing and using a heart monitor and communicating with a telephone coach are all part of the study procedures.

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

A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2- Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

Date Added
September 28th, 2021
PRO Number
Pro00113619
Researcher
Frank Brescia

List of Studies


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

The purpose of this study is to understand if CX-2009 when given by itself to participants with advanced breast cancer is safe and has anti-tumor activity. CX-2009 will be combined with CX-072 to understand if the combination of these two drugs is safe and has anti-tumor activity in participants with advanced triple negative breast cancer.

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



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