A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Date Added
September 12th, 2024
PRO Number
Pro00136971
Researcher
Praneeth Baratam

List of Studies

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

This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

Date Added
September 10th, 2024
PRO Number
Pro00136698
Researcher
Thai Ho

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 locally advanced or metastatic solid tumors with oncogene amplifications 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 BBI-355. This is the first study to test the study medicine BBI-355 in humans; BBI-355 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug orally, blood and urine samples, diary entries, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, muscle weakness, dizziness, and headaches. 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 1b study of sovilnesib (an oral KIF18A inhibitor) in subjects with advanced high grade serious ovarian cancer

Date Added
September 10th, 2024
PRO Number
Pro00136860
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for subjects that have been diagnosed with advanced high grade serious ovarian cancer. The investigational drug used in this study is Sovilnesib. The main purpose of this study is to is to establish the recommended phase 2 dose, which will be considered the optimal dose, of Sovilnesib. Additionally, this study will examine the safety, tolerability and preliminary efficacy of Sovlinesib. The total time you will be on the study treatment will depend on if you have any unwanted side effects and how your cancer is responding to treatment.

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

A Phase 3, Multicenter, Randomized, Double-blind, Single-dose Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects with Glenohumeral Osteoarthritis.

Date Added
September 10th, 2024
PRO Number
Pro00134950
Researcher
Josef Eichinger

List of Studies


Keywords
Arthritis, Bone, Drug Studies, Pain
Summary

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution) and the current treatment of TCA-IR (Triamcinolone Acetonide, immediate release). The study drug is administered through an ultrasound-guided injection to the affected shoulder. Forty percent of subjects will receive Zilretta, forty percent will receive TCA-IR and twenty percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-85 years of age, BMI under 40, who have been diagnosed with Osteoarthritis of the shoulder by x-ray and has had pain for over 15 days out of the past month. The study has 10 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

Institution
MUSC
Recruitment Contact
Robert Reis
8437925025
reisb@musc.edu

Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

Date Added
August 27th, 2024
PRO Number
Pro00138907
Researcher
David Marshall

List of Studies


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

This study is for patients with metastatic renal cell carcinoma (RCC). The study is being done to compare overall survival (OS) between patients receiving standard systemic therapy (ST) right away versus delaying systemic therapy and instead starting with irradiation (SAbR) to all metastatic sites and reserving systemic therapy when/if the patient progresses. Also, compare the average AE score between SAbR+ST arm and ST only arm. The study drugs being used as ST are standard of care. Patients will expect to remain in the study for up to 24 months.

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

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma (INTERCON)

Date Added
August 26th, 2024
PRO Number
Pro00136417
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 mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.

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

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



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