EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Date Added
January 11th, 2022
PRO Number
Pro00116527
Researcher
Kimberly Green

List of Studies

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

This study is for patients who have been diagnosed with multiple myeloma. The investigational drug in this study is idecabtagene vicleucel (ide-cel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to have about 8 clinic visits and to be in this study for up to 3 months after receiving the study drug and in follow up for up to 15 years.

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

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 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Date Added
December 14th, 2021
PRO Number
Pro00116496
Researcher
Brian Hess

List of Studies


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

This study is for subjects with Diffuse large B-cell lymphoma (DLBCL) that has gotten worse or come back after two or more treatments. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug combination of loncastuximab tesirine in combination with one of four other anti-cancer agents is a safe and effective treatment for relapsed or refractory B-cell Non-Hodgkin Lymphoma. Treatment will be assigned by a system in a sequence unless the subject has received the combination drug (the drug that is not locastuximab). This means the first enrolled subject will be assigned to arm C, the second to arm E, and so on. The subject will be seen approximately once a week during treatment, and may remain in the study for up to 3 years.

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

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients with MET Overexpressing Advanced Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00115889
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 advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.

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

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

Date Added
October 19th, 2021
PRO Number
Pro00113440
Researcher
Brian Orr

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 Phase 2 Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on or Are Intolerant to a PD-1/L-1, 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 Mecbotamab Vedotin (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 Mecbotamab Vedotin by intravenous (IV) infusion. The purpose of this study is to understand how Mecbotamab Vedotin works with and without nivolumab in fighting cancer cells; to see what side effects Mecbotamab Vedotin has when given alone and in combination with nivolumab; to understand how the body absorbs and processes Mecbotamab Vedotin; and to understand whether Mecbotamab 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). 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 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 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

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



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