A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels

Date Added
January 23rd, 2024
PRO Number
Pro00131570
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.

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

A multi-site, open-label, Phase II, randomized, controlled Trial to compare the Efficacy of RO7198457 Versus Watchful Waiting in resected, Stage II (high risk) and Stage III Colorectal Cancer patients who are ctDNA positive following resection

Date Added
October 10th, 2023
PRO Number
Pro00129948
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn about the effects of an experimental treatment called RO7198457. This study is for patients with Stage II or III colon or rectal cancer, which has been treated surgically and with chemotherapy, and your blood has been found to have ctDNA (circulating tumor DNA) during a ctDNA screening test. RO7198457 (autogene cevumeran) is an immunotherapy that is individualized to a tumor and designed to mount an immune response against it. Treatment includes RO7198457 being injected in the vein, physical exams, blood sample collections, and CT scans for up to a year. Risks include fatigue, fever, and headache. Patients may or may not receive direct benefit while on the study, however, information collected during this study will help people with colon and rectal cancer in the future. RO7198457 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease.

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

A Phase Ib, Open Label, Multicenter Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination with 2X-121 in Patients with Advanced Solid Tumors

Date Added
September 12th, 2023
PRO Number
Pro00127917
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This is a clinical research study that is using an investigational product, 2X-121, as a possible treatment for diagnosed advanced solid tumors, both alone and in combination with another investigational product, dovitinib. Both drugs are taken orally and are also investigational, meaning that the FDA (the U.S. Food and Drug Administration) has not yet approved them as a treatment for any disease. The results of this study and previous studies will be used to design future studies to improve treatment of advanced solid tumors. This study will help determine the safety of 2X-121 and dovitinib. The study will help determine a safe and effective dose of 2X-121 alone and a safe and effective dose of dovitinib when given in combination with 2X-121. Subjects participating in this study will contribute to the development of a drug which has the potential to become a treatment option for them and others in the future. The expected duration of the study for participants is 24 months, this research study will involve two parts. Participants in Part 1 will be assigned to receive either 600 mg, 800 mg, or 1000 mg of 2X-121 daily for 28 days. Participants in Part 2 will be assigned to receive the chosen daily dose of 2X-121 as decided after Part 1, along with dovitinib at either a 300 mg, 400 mg, or 500 mg dose once daily for five days followed by 2 days without dovitinib. The 5 days on / 2 days off schedule will repeat for 28 days. Some reasonably foreseeable risks and discomforts include: Fatigue, Urine discoloration, diarrhea, nausea, vomiting, decreased appetite, rashes. It is hoped that the information gained from the study will help in the treatment of future patients with conditions like yours.

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

An Open-Label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Date Added
August 8th, 2023
PRO Number
Pro00127767
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn about the effects of an experimental treatment called E7386. This study is for patients with hepatocellular carcinoma, colorectal cancer, endometrial cancer, or other solid tumors. E7386 in combination with levantinib fight tumors by decreasing tumor density. The purpose of this study is to learn about the effects of an experimental treatment called E7386. E7386 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease. Levantinib is FDA approved and has been previously used to treat cancer, however, it is considered experimental in combination with E7386.

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

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

Date Added
June 21st, 2023
PRO Number
Pro00129646
Researcher
Toros Dincman

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with advanced rectal cancer. This study is being done to see if we can increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation.
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

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

Randomized Phase II trial of encorafenib and cetuximab with or without nivolumab (NSC #748726) for patients with previously treated, microsatellite stable, BRAFV600E metastatic and/or unresectable colorectal cancer

Date Added
March 14th, 2022
PRO Number
Pro00127342
Researcher
Toros Dincman

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with colorectal cancer. This study is being done to see if we can lower the chance of colorectal cancer growing or spreading by adding a drug to the usual combination of drugs.

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

DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Date Added
August 27th, 2019
PRO Number
Pro00091613
Researcher
Toros Dincman

List of Studies

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

This study is for patients that have been diagnosed with advanced prostate cancer with bone metastases.The purpose of this research study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. The addition of radium-223 to docetaxel could have an overall survival benefit, but it could also cause side effects. The study drugs, radium-223 and docetaxel, are considered experimental drugs that are being evaluated together as a combination therapy for participants with certain solid tumors (cancer). Patients will be seen at MUSC for about 8 months. After they finish the treatment, the doctor will continue to watch the patient for side effects and follow their condition for the rest of their life, or for as long as they wish to remain on the study.

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



-- OR --