Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Study of GBR 1342, a CD38 / CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
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
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced / Metastatic Solid Tumors
This study is an open-label Phase 1 / Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced / metastatic solid tumors.
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse / refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective, Interventional Trial
This is a Phase 1, Open-label, Dose Escalation study to investigate SNDX-6352 in subjects with active cGVHD.
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic / Pharmacodynamic Profile of VX-803 / M4344 as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin, gemcitabine, and cisplatin to determine the safety and maximum tolerated dose.
Galunisertib and Paclitaxel in Treating Patients with Metastatic Androgen Receptor Negative or Triple Negative Breast Cancer
This phase I trial studies the side effects and best dose of galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, 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 glunisertib together with paclitaxel may kill more tumor cells.
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
Multiple Cancer Types
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.
Breast, Endocrine, Esophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic
Venetoclax and Selinexor in Treating Patients with Relapsed or Refractory High Risk Hematologic Malignancies
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.