Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical
study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in
participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase
1b of this clinical study is learn about the effectiveness of the recommended dose of
KITE-197 in participants with r/r LBCL.

The primary objectives of this study are:

Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the
target dose level for Phase 1b.

Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by
the complete remission (CR) rate.

This phase II trial studies how well pembrolizumab after standard treatment with radiation plus the following chemotherapy drugs: cisplatin or carboplatin, plus etoposide works in treating patients with limited stage small cell lung cancer (LS-SCLC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after standard treatment with radiation plus chemotherapy may increase the ability of the immune system to fight LS-SCLC.

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether
BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral
neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been
exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized,
placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label
BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects
with recurrent malignant gliomas (glioblastoma, or GBM).

Genes contain genetic code which tell the body which proteins to make. Many types of cancer
are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways
to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D
mutation in the KRAS gene is common in people with some solid tumors.

ASP3082 is a potential new treatment for certain solid tumors in people who have the G12D
mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need
to understand how it is processed by and acts upon the body. This information will help find
a suitable dose and to check for potential medical problems from the treatment.

People in this study will be adults with locally advanced, unresectable or metastatic solid
tumors with the G12D mutation in their KRAS gene (G12D mutation). Locally advanced means the
cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by
surgery. Metastatic means the cancer has spread to other parts of the body. They will have
been previously treated with standard therapies or refused to receive those treatments. In
the European Union (EU) and South Korea, people who have refused to receive treatment with
standard therapies cannot take part.

The main aims of the study are: to check the safety of ASP3082 by itself and together with
cetuximab (a common cancer medicine), how well it is tolerated, and to find a suitable dose
of ASP3082 by itself and together with cetuximab.

This is an open-label study. This means that people in this study and clinic staff will know
that they will receive ASP3082.

This study will be in 2 parts. In Part 1, different small groups of people will receive lower
to higher doses of ASP3082, by itself, or together with cetuximab. Only people with
colorectal cancer will receive ASP3082 together with cetuximab. Any medical problems will be
recorded at each dose. This is done to find suitable doses of ASP3082 by itself or together
with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of
ASP3082. A medical expert panel will check the results from this group and decide if the next
group can receive a higher dose of ASP3082. The panel will do this for each group until all
groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses
have been selected for Part 2.

In Part 2, other different small groups of people will receive ASP3082 by itself or together
with cetuximab, with the most suitable doses worked out from Part 1. This will help find a
more accurate dose of ASP3082 to use in future studies.

ASP3082, and cetuximab (if used), will be given through a vein. This is called an infusion.
Each treatment cycle is 21 days long. They will continue treatment until: they have medical
problems from the treatment they can't tolerate; their cancer gets worse; they start other
cancer treatment; they ask to stop treatment; they do not come back for treatment.

People will visit the clinic on certain days during their treatment, with extra visits during
the first 2 cycles of treatment. During these visits, the study doctors will check for any
medical problems from ASP3082 by itself or together with cetuximab. At some visits, other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse,
breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people
treated with ASP3082 together with cetuximab.) Tumor samples will be taken during certain
visits during treatment and when treatment has finished.

People will visit the clinic within 7 days after stopping treatment. The study doctors will
check for any medical problems from ASP3082 by itself or together with cetuximab. Other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, urine and blood tests and vital signs. After this, people will continue to visit
the clinic every 9 weeks. This is to check the condition of their cancer. They will do this
until 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer
treatment, they ask to stop treatment, or they do not come back for treatment.

Also, people may visit the clinic at 30 days and 90 days after stopping treatment. At the
30-day visit, the study doctors will check for any medical problems from ASP3082 by itself or
together with cetuximab. People will have their vital signs checked and have some bloo

This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).

The goal of this clinical trial is to test a new drug plus standard treatment compared with
standard treatment alone in patients with advanced head and neck squamous cell carcinoma and
cholangiocarcinoma.

The main questions it aims to answer are:

- is the new drug plus standard treatment safe and tolerable

- is the new drug plus standard treatment more effective than standard treatment

Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.