SPRING 2023 CLINICAL CORNER

Faculty discuss clinical research

onclive

UF Health Cancer Center faculty recently participated in interviews with OncLive about their research.

John Ligon, M.D.

Mansi Dalal, M.D.

Jordan Milner, M.D.

John Ligon, M.D., Mansi Dalal, M.D., and Jordan Milner, M.D.

Jonathan Chatzkel, M.D.

Burak Zeybek, M.D.


New Clinical Trials Open for Enrollment

Nautilus: OKI-179 Plus Binimetinib in Patients with NRAS-mutated Melanoma

This Phase 2 trial is assessing the efficacy of oral OKI-179 combined with binimetinib in patients with advanced (unresectable Stage III/IV) NRAS-mutated melanoma previously treated with or ineligible for immune checkpoint inhibitors (ICI).  OKI-179 is a novel, selective, and orally available largazole-derived HDAC inhibitor. This trial will also assess efficacy, safety, and tolerability of this treatment combination.

Principal Investigator: Bently Doonan, M.D. Cell: 843-340-0085

Ember 3: Imlunestrant plus investigators choice, and Imlunestrant Plus Abemaciclib in Participants with ER+, HER2- Advance Breast Cancer

This Phase 3 open label trial is looking at the combination of Imlunestrant plus investigator’s choice of endocrine therapy or Imlunestrant plus Abemaciclib  in patients with estrogen receptor positive, HER2 negative locally advanced or metastatic breast cancer.  Imlunestrant (LY3484356) is an oral SRED with antitumor activity. Imlunestrant’s antitumor activity is enhanced by the combination with abemaciclib. This trial is comparing the progression free survival of these two treatments arms while also assessing effectiveness, safety, and tolerability.

Principal Investigator: Karen Daily, D.O. Cell: 352-222-1423

Study of LY3537982 in Cancer Patients with KRAS G12C Mutation

This open label Phase 1 study is evaluating the safety, tolerability and efficacy of an oral KRAS G12C inhibitor (LY3539782) in patients with KRAD G12C mutant solid tumors.  LY3539782 is daily oral medication given in 21 day cycles, either as monotherapy or in combination with pembrolizumab. Enrollment opportunities are available for KRAS-inhibitor naïve NSCLC as well as NSCLC with prior exposure to KRAS-inhibitors, with future enrollment opportunities for colorectal and pancreatic cancers.  Subjects must have a documented KRAS G12C mutation in tumor tissue or circulating tumor DNA, be able to tolerate oral therapy, and have no remaining appropriate standard of care treatment options. 

Principal Investigator: Thom George, M.D. Cell: 352-339-6672

AB-101 as Monotherapy and In Combination with Rituximab in Patients with Relapsed/Refractory B-Cell Non-Hodgkins Lymphoma

This an open-label, Phase 1 / 2 trial is evaluating the safety and anti-tumor activity of AB-101 monotherapy or AB-101 in combination with Rituximab in patients with RR B-Cell NHL.  AB-101 is comprised of ex vivo-expanded allogeneic cord blood-derived natural killer (NK) cells cryopreserved in an infusion-ready suspension.  Treatment will involve a lymphodepleting regimen with Cyclophosphamide and Fludarabine, IL2, and AB 101 with or without Rituximab.  

Principal Investigator: Erin Dean, M.D. Cell: 813-418-1716