Skip to main content

Clinical Trials Search at Vanderbilt-Ingram Cancer Center



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

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

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Phase I

This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
Phase I
I
Davis, Elizabeth
NCT04198766
VICCPHI2135

RBS2418 Evaluation in Subjects With Unresectable or Metastatic Tumors

Phase I

RBS2418 (investigational product) is a specific immune modulator, working through
ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor
immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine
monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine
production in the tumors. RBS2418 has the potential to be an important therapeutic option for
subjects both as monotherapy and in combination with checkpoint blockade. This study is an
open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in
combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable,
recurrent or metastatic tumors.
Phase I
I
Berlin, Jordan
NCT05270213
VICCPHI2289

Clinical Trials Search CTA Inline Referral Form

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