Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This trial will include 2 portions (phase 1 and phase 2).

The first portion will be a Phase I, open label, dose escalation study to establish the
maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in
combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced
pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study.

The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of
XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized
on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU
(Arm 2).

This phase Ib/II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is an enzyme inhibitor. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Venetoclax and decitabine are commonly given together for older patients with AML ASTX727 (a pill form of decitabine + cedazuridine) has been found to be equal to decitabine (given intravenously), and this part of the study is to confirm that venetoclax and ASTX727 is as safe as venetoclax and decitabine given intravenously. This study allows for lowering doses of study drugs to assure the dose chosen for the randomized study (second portion of this trial) is safe and tolerable for people. Giving ASTX727 in combination with venetoclax may help in the treatment of patients with higher-risk acute myeloid leukemia.

The primary objective of this study is to identify the recommended dose for expansion (RDE)
(and recommended schedule) and/or the maximum tolerated dose (MTD), and characterize the
safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with
azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled
into the Phase 1a dose escalation part of the study. Every effort will be made to ensure
approximately 50% of all subjects enrolled in this study will be subjects with the tumors of
special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the
bladder (TCC). Subjects with other solid tumor types are also eligible provided study
selection criteria are met and they do not exceed 50% of all enrolled subjects. The study
will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study
will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to
20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the
fasting state with water at least 1 hour before food or at least 2 hours after food. The
Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected
from the dose escalation data by the safety monitoring committee (SMC), to obtain additional
safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects.
The study will be expanded into a Phase 2 study via protocol amendment which will then assess
the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further
clinical development. Subjects will be dosed until unacceptable toxicity, disease progression
per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of
treatment for other protocol allowed reason (eg, subject refusal), any other administrative
reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes,
dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once
every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).

This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patients life span compared to the usual approach.

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab-hyaluronidase in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab-hyaluronidase is a monoclonal antibody, daratumumab, that may interfere with the ability of cancer cells to grow and spread, and hyaluronidase, which may help daratumumab work better by making cancer cells more sensitive to the drug. Giving lenalidomide and dexamethasone with daratumumab-hyaluronidase may work better in treating patients with smoldering myeloma.