A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
This will be a long-term multi-center study to comprehensively study patients with primary liver cancer (PLC).ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that START-001 is a two-part, open label, FIH Phase 1/2 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of STAR0602 as a monotherapy in subjects with advanced solid tumors. ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)This is a single-arm, phase II study of patients with advanced HCC with Child-Pugh B cirrhosis who are eligible for first-line treatment with T300+D.ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II trial evaluating the combination of XL-092 with durvalumab and tremelimumab in unresectable HCC. This phase II trial design will be preceded by a safety lead in of 9-12 patients.NCT06698250Sukeshi Patel Arora, MD

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsA Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsDose-Escalation Part (Part 1)Primary Objectives:•To assess the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumorsBackfill Part (Part 2)Primary Objectives:•To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumorsDose-Expansion Part (Part 3)Primary Objectives:•To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma•To determine the recommended phase 2 dose (RP2D) of YL217NCT06859762Sukeshi Patel Arora, MD

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Colorectal Cancer (FRUITION)A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Colorectal Cancer (FRUITION)This will be a multi-center, randomized phase II trial of fruquintinib + TAS-102 as compared to fruquintinib.NCT06992258Sukeshi Patel Arora, MD

Modulation of Sorafenib induced autophagy using hydroxychloroquine in hepatocellular cancer Modulation of Sorafenib induced autophagy using hydroxychloroquine in hepatocellular cancer The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).NCT03037437Sukeshi Patel Arora, MD

Biomarker development for predicting immune checkpoint therapy efficacy of hepatocellular carcinoma (CTMS# 22-0050)Biomarker development for predicting immune checkpoint therapy efficacy of hepatocellular carcinoma (CTMS# 22-0050)We propose to test whether H1 and H2 clustering can distinguish patients responsive or resistant to the combination therapy with immunotherapy in a prospective clinical study.ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer MONITOR-Breast: Monitoring cell-free tumor DNA as a marker of recurrence in Breast Cancer This is a prospective, observational study designed to evaluate the clinical validity of Myriad Genetics’ MRD test in patients diagnosed with breast cancer. It is expected that enrollment will be split between the different breast cancer subtypes defined by immunohistochemistry (HR+/HER2-, HER2+ (HR+ and HR-), TNBC) and according to BINV-A of National Comprehensive Cancer Network guidelines with ER+ status used here as >10% of nuclei staining.ClinicalTrials.gov registration not requiredMarcela Mazo Canola MD

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.NCT06479135Zohra Nooruddin MD