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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Venetoclax and Selinexor in Treating Patients with Relapsed or Refractory High Risk Hematologic Malignancies

Multiple Cancer Types

This phase Ib trial studies the side effects and best dose of venetoclax and selinexor and how well they work in treating patients with high risk hematologic malignancies such as diffuse large B-cell lymphoma, multiple myeloma, or acute myeloid leukemia that have come back (recurrent) or do not respond to treatment (refractory). Venetoclax functions by inhibiting or slowing down a protein in the body called bcl-2, which is involved in slowing down the normal process by which old cells in the body are cleared (called apoptosis). Selinexor functions by trapping “tumor suppressing proteins” within the cell and causing the cancer cells to die or stop growing. This study examines the effects, if any, of selinexor and venetoclax on high risk hematologic malignancies and on the body, including any side-effects.
Hematologic, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Phase I
I
Byrne, Michael
NCT03955783
VICCHEM1755

Dose Escalation and Expansion Study of GSK3359609 in Subjects With Selected Advanced Solid Tumors (INDUCE-1)

Multiple Cancer Types

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
Lung, Non Small Cell, Phase I
I
Horn, Leora
NCT02723955
VICCTHOP17113

ASTX727 and FT-2102 in Treating Patients with IDH1-Mutated Recurrent or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia

Multiple Cancer Types

This phase Ib / II trial studies the side effects and best dose of FT-2102 when given together with ASTX727 in treating patients with IDH1-mutated myelodysplastic syndrome or acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). ASTX727 is an oral deoxyribonucleic acid (DNA) methyltransferase (DNMT) inhibitor. DNA methylation is necessary for cell differentiation and development. Changes to the methylation profile can lead to DNA instability which can cause diseases like cancer. DNMT inhibitors target and inhibit these changes. FT-2102 is an isocitrate dehydrogenase 1 (IDH1) inhibitor. IDH1 is a type of protein involved in metabolism, or the process of providing the body’s cells with energy. FT-2102 may stop the abnormal IDH1 protein and may reduce 2-HG levels in diseased cells to levels found in normal cells. Giving ASTX727 and FT-2102 may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia compared to ASTX727 and FT-2102 alone.
Leukemia, Myelodysplastic Syndrome, Phase I
I/II
Ferrell, Paul
NCT04013880
VICCHEM18165

Capecitabine and Radiation Therapy after Surgery in Treating Patients with Non-Metastatic Invasive Breast cancer

Multiple Cancer Types

This phase I trial studies how well capecitabine and radiation therapy after surgery work in treating patients with invasive breast cancer that has not spread to other places in the body. Drugs used in chemotherapy, such as 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 capecitabine and radiation therapy together may kill more tumor cells in patients with invasive breast cancer compared to capecitabine or radiation therapy alone.
Breast, Phase I
I
Chak, Bapsi
NCT03958721
VICCBREP1898

A Study of ZN-c5 in Subjects With Breast Cancer

Multiple Cancer Types

This is a Phase 1 / 2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+ / HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
Breast, Phase I
I/II
Abramson, Vandana
NCT03560531
VICCBREP1899

A Phase 1 / 2 Study to Evaluate SNDX- 6352 in Subjects With Active cGVHD

Multiple Cancer Types

This is a Phase 1 / 2, Open-label, Dose Escalation study to investigate SNDX-6352 in subjects with active cGVHD.
Hematologic, Phase I
I
Jagasia, Madan
NCT03604692
VICCBMTP18109

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

Multiple Cancer Types

The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Lung, Non Small Cell, Phase I
I/II
Horn, Leora
NCT03840915
VICCTHO1920

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