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

A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerA Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder CancerThis is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.ClinicalTrials.gov registration not requiredAhmed Mansour Elkenany MD

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of
Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastatic Breast Cancer After Progression on Previous This is a Phase 2, randomized, active-controlled, parallel-group, multisite, open-label studyof belzutifan plus fulvestrant versus everolimus plus ETPC (fulvestrant or exemestane) inparticipants with ER+/HER2- unresectable, locally advanced, or mBC.ClinicalTrials.gov registration not requiredSaba Shaikh, MD