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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

9-ING-41 in Patients With Advanced Cancers

Multiple Cancer Types

GSK-3 is a potentially important therapeutic target in human malignancies. The Actuate 1801
Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3
inhibitor, as a single agent and in combination with cytotoxic agents, in patients with
refractory cancers.
Miscellaneous, Phase I
Davis, Elizabeth

Testing Lutetium Lu 177 Dotatate in Patients with Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors


This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Ramirez, Robert

CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC

Multiple Cancer Types

The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug
for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint
inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is
a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1
up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint
inhibitors may lead to improved long-term outcomes for patients with NSCLC who have
suboptimal response to ICI therapy.
Lung, Non Small Cell
Maldonado, Fabien

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Phase I

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound
that targets both EGFR with TGF. Based on preclinical data, this bifunctional antibody may
exert synergistic activity in patients with EGFR-driven tumors.
Phase I
Gibson, Mike

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)

Multiple Cancer Types

The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of
ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
regimen comprising fludarabine, cyclophosphamide, and ALLO-647
Lymphoma, Phase I
Oluwole, Olalekan

A Study of ASP3082 in Adults With Previously Treated Solid Tumors

Phase I

ASP3082 is a potential new treatment for people with certain solid tumors. 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 check for potential
medical problems from the treatment.

People in this study will be adults with locally advanced or metastatic solid tumors with
changes in their KRAS gene (G12D mutation). Metastatic means the cancer has spread to other
parts of the body. They will have been previously treated with all available standard
therapies or refused to receive those treatments.

There are 2 main aims of this study. The first is to learn if people with certain solid
tumors have any medical problems after receiving different doses of ASP3082, alone or
together with a common cancer drug, cetuximab. Only people with colorectal cancer will
receive ASP3082 and cetuximab. The second aim is to find a suitable dose of ASP3082, alone or
with cetuximab to use in future studies. This study will be in 2 parts. In Part 1, different
small groups of people will receive lower to higher doses of ASP3082, alone or with
cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable
doses of ASP3082, alone or 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 taken ASP3082 (alone or with cetuximab) or until
suitable doses have been selected for Part 2.

In Part 2, other different small groups of people will receive ASP3082, alone or 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; 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, and/or cetuximab. At some visits, other checks will include a
medical examination, laboratory tests and vital signs. Vital signs include temperature,
pulse, breathing rate, and blood pressure. Also, blood and urine samples will be taken. 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, and/or cetuximab. Other checks will include a
medical examination, laboratory tests and vital signs. Then, they 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, and/or cetuximab. People will have their vital signs
checked and have some laboratory tests. At the 90-day visit, the study doctors will check for
any medical problems from ASP3082, and/or cetuximab and people will have their vital signs
checked. 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,
their cancer is worse, they start other cancer treatment, they ask to stop treatment, or they
do not come back for treatment.
Phase I
Berlin, Jordan

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Multiple Cancer Types

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.

ABBV-453 is an investigational drug being developed for the treatment of R/R MM. This study
will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21
adult participants with R/R MM will be enrolled in the study in approximately 12 sites

Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
Multiple Myeloma, Phase I
Baljevic, Muhamed

Talazoparib for the Treatment of BRCA 1/2 Mutant Metastatic Breast Cancer


This phase II trial studies how well talazoparib works for the treatment of breast cancer with a BRCA 1 or BRCA 2 gene mutation that has spread to other places in the body (metastatic). Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called poly (ADP-ribose) polymerases also called PARPs. PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become tumor cells. Tumor cells may be killed by a study drug, like talazoparib, that stops the normal activity of PARPs. Talazoparib may be effective in the treatment of metastatic breast cancer with BRCA1 or BRCA2 mutations.
Abramson, Vandana

Ruxolitinib in Preventing Breast Cancer in Patients with High Risk and Precancerous Breast Lesions


This phase II trial studies how well ruxolitinib before surgery works in preventing breast cancer in patients with high risk and precancerous breast conditions. Ruxolitinib may changes the breast cell when administered to participants with precancerous breast conditions. Ruxolitinib may stop the growth of cells by blocking some of the enzymes needed for cell growth.
Meszoely, Ingrid

Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

Phase I

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety,
tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid
Phase I
Berlin, Jordan

To learn more about any of our clinical
trials, call 615-936-8422.