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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Multiple Cancer Types

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue
in patients with NPM1-m AML.
Leukemia, Phase I
I/II
Savona, Michael
NCT04067336
VICCHEMP20122

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Multiple Cancer Types

This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy as single agents or combinations, in participants with
metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment
arm-specific definition. Eligible participants with mCRC will be enrolled into specific
treatment arms based on their biomarker assay results.
Colon, Phase I, Rectal
I
Ciombor, Kristen
NCT04929223
VICCGIP2158

Study of DF1001 in Patients With Advanced Solid Tumors

Multiple Cancer Types

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
Miscellaneous, Phase I
I/II
Berlin, Jordan
NCT04143711
VICCPHI2064

Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Multiple Cancer Types

The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Leukemia, Phase I
I/II
Savona, Michael
NCT04657081
VICCHEMP20102

Gabapentin plus Ketamine for the Prevention of Acute and Chronic Pain in Patients with Locally Advanced Head and Neck Cancer Undergoing Chemoradiation

Multiple Cancer Types

This phase I/II trial studies the side effects and best dose of a combination of gabapentin and ketamine and to see how well it works to prevent acute and chronic pain in patients receiving chemotherapy and radiation therapy (chemoradiation) for head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced). Gabapentin is a medication that is commonly used to treat nerve related pain. Specifically, it has been used to treat pain involving the mouth, throat and nasal passages in head and neck cancer patients treated with radiation. Ketamine is a type of general anesthetic that blocks pathways to the brain involved with sensing pain. This trial may help doctors determine how patients tolerate the combination of gabapentin and ketamine and to find the correct dosing for ketamine in those taking gabapentin. This will be the basis for a future, larger study to look at how effective this combination is at reducing and/or preventing pain in head and neck cancer patients.
Head/Neck, Phase I
I/II
Lockney, Natalie
NCT05156060
VICCHNP2173

A Study of Engineered Donor Grafts (Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Multiple Cancer Types

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft
("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and
Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell
transplant transplantation for hematologic malignancies.
Leukemia, Myelodysplastic Syndrome, Phase I
I
Dholaria, Bhagirathbhai
NCT04013685
VICCCTTP2086

Selinexor and Venetoclax in Combination with Chemotherapy for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

Multiple Cancer Types

This phase I trial evaluates the side effects and best dose of selinexor and venetoclax in combination with chemotherapy in treating patients with acute myeloid leukemia or acute leukemia of ambiguous linage that has come back (relapsed) or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Selinexor may stop the growth of cancer cells by blocking CRM1, which help the body's immune system to find and kill cancer cells. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as granulocyte colony-stimulating factor, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving venetoclax and selinexor with chemotherapy may help control the disease in patients with acute myeloid leukemia or acute leukemia of ambiguous lineage.
Leukemia, Pediatric Leukemia, Pediatrics, Phase I
I
Smith, Brianna
NCT04898894
VICCPEDP2235

Phase 1b Combo w/ Ribociclib and Alpelisib

Multiple Cancer Types

This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are
as follows:

Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).

Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
Breast, Phase I
I
Abramson, Vandana
NCT05508906
VICCBREP2267

A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

Multiple Cancer Types

The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic, Liver, Phase I
I
Goff, Laura
NCT04008797
VICC-DTPHI23106

A Study of ASP3082 in Adults With Previously Treated Solid Tumors

Phase I

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
Phase I
I
Berlin, Jordan
NCT05382559
VICCPHI2207

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