Other Novel Therapies Archives - Cholangiocarcinoma Foundation

CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.

This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.

Early phase 1 study evaluating the safety of autologous dendritic cells (immune cells generated from patients’ own white blood cells, grown in a special lab, and trained to stimulate the immune system against the tumor) and a vaccine (Prevnar) in treating patients with liver cancer that cannot be removed by surgery after undergoing radiotherapy.

TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.

This Phase 2 study will be conducted in conjunction with the companion harvest protocol protocol in patients with measurable disease who have lesions that can be resected or biopsied for Tumor Infiltrating Lymphocyte(TIL) growth. The Treatment Phase begins once the cells exceed the cell growth and potency requirements in the companion protocol.

This is a multicenter, open-label, uncontrolled, repeat-dose phase 1/2a study designed to evaluate the safety profile and to determine the Recommended Dose of GNS561 in patients with advanced advanced primary liver cancer (Hepatocarcinoma, Intrahepatic Cholangiocarcinoma). This study consists of 2 parts: escalation and expansion phase.

This is a trial of combining a HDAC inhibitor and a PD1 inhibitor (immunotherapy drug) to make cholangiocarcinoma more sensitive to immunotherapy. This is based on laboratory data that shows HDAC inhibitors can make tumors more sensitive to immunotherapy.

This study is a dose escalation study to determine the safety and tolerability of Ceramide NanoLiposome in patients with advanced solid tumors.

Other Novel Therapies

CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients with Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers

GNS561-CL-I-Q-0211: Phase 1/2 Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients with Primary Liver Cancer which includes Intrahepatic cholangiocarcinoma patients

A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma

Ceramide NanoLiposome in Patients with Advanced Solid Tumors