General Oncology to Present Phase 1 SHARON Trial Results for BRCA/PALB2-Mutated Cancers at ESMO 2025
核心洞察
General Oncology (搜索) will present preliminary Phase 1 results from the SHARON trial evaluating GO-4 (搜索) therapy in patients with BRCA (搜索)/PALB2 (搜索)-mutated pancreatic and breast cancers at ESMO 2025.
The GO-4 (搜索) regimen combines melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cell infusion as an Advanced Redox Modulation approach for metastatic cancers (搜索).
The Phase 1 study is designed to evaluate safety, feasibility, and preliminary efficacy in patients with advanced pancreatic ductal adenocarcinoma (搜索) or breast cancer (搜索).
General Oncology (搜索) announced it will deliver a poster presentation featuring preliminary results from its ongoing Phase 1 SHARON trial at the European Society of Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. The clinical-stage biopharmaceutical company will present data on GO-4 (搜索), its patented Advanced Redox Modulation regimen, in patients with advanced pancreatic ductal adenocarcinoma (搜索) or breast cancer (搜索) harboring inherited BRCA (搜索)/PALB2 (搜索) mutations.
SHARON Trial Design and Patient Population
The SHARON trial (NCT04150042) is a Phase 1 study designed to evaluate the safety, feasibility, and preliminary efficacy of GO-4 (搜索) in patients with advanced pancreatic or breast cancer (搜索). The GO-4 regimen consists of melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cell infusion. Patients enrolled to date have had an inherited BRCA (搜索)/PALB2 (搜索) mutation, though the trial will expand to include patients with or without these mutations for the remainder of the study.
ESMO Presentation Details
The poster presentation, titled "The SHARON Trial: Melphalan, BCNU, Hydroxocobalamin, Ascorbic Acid, and Stem Cells for Pancreatic and Breast Cancer (搜索) and an Inherited BRCA (搜索)/PALB2 (搜索) Mutation," will be presented by Kenneth H. Yu, M.D., from Memorial Sloan Kettering Cancer Center, who serves as the trial's Principal Investigator. The presentation is scheduled for Sunday, October 19 at 12:00-12:45 CEST in the Poster Area, Hall 25, with abstract number 2228P.
Advanced Redox Modulation Approach
General Oncology (搜索)'s GO-4 (搜索) therapy represents what the company describes as an Advanced Redox Modulation regimen. This investigational therapy combines multiple components including the alkylating agents melphalan and BCNU, along with hydroxocobalamin, ascorbic acid, and autologous stem cell infusion. The company is developing this first-in-class approach specifically for metastatic cancers (搜索) and other proliferative diseases.
Company Focus on Metastatic Cancer Treatment
General Oncology (搜索) positions itself as dedicated to pioneering first-in-class medicines for metastatic cancers (搜索). The company is currently completing the Phase 1 SHARON trial for metastatic cancers in the setting of BRCA1/2 or PALB2 (搜索) mutations, with a stated commitment to advancing transformative therapies for cancer patients.