FEBRUARY 2024 CLINICAL CORNER

Highlighted Clinical Trials Open for Enrollment

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

NP-G2-044 in Combination with anti-PD-1 Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies

This is a Phase 2 trial of a novel fascin inhibitor (NP-G2-044) given in combination with standard of care anti-PD1 treatment, in solid tumor subjects with prior progression on anti-PD1 treatment. Subjects will received oral NP-G2-044, once daily on days 1-28 of a 28-day cycle, in addition to anti-PD1 therapy in accordance with the package insert.  Primary study objective is to assess preliminary anti-tumor efficacy of NP-G2-044 when administered in combination with anti-PD1 therapy. 

Principal Investigator: Thomas George, M.D., FACP 

Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors

This is a phase II multicenter study of Lutetium Lu 177 Dotate (Lu-177 Dotate) in combination with Triapine vs. Lu-177 Dotate alone in metastatic well-differentiated somatostatin receptor-positive neuroendocrine tumors, after the failure of at least one prior line of systemic treatment. Subjects will be randomized 1:1 to either Lu-177 Dotate w/ oral triapine vs. Lutathera alone.   Treatment is given in 8 week cycles, with IV Lu-177 Dotate on Day 1 of each cycle, with Triapine 150 mg QD Days 1-14.  Participants can receive up to 4 Cycles of treatment. 

Principal Investigator: Kathryn Hitchcock, M.D.

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy for Limited mCRC (ERASur)

This phase III trial compares total ablative therapy (TAT) and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The ablative local therapy will consist of stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for Limited mCRC. This study is based on current common practice, and will pragmatically evaluate the safety, benefits versus risks, and survival impact of the integration of these treatments for Limited mCRC. 

Principal InvestigatorKathryn Hitchcock, M.D.

A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev)(NUC-3373 Q1 week versus Q2 weeks on a 28-day cycle) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.  The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

Principal Investigator: Thomas George, M.D., FACP