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General Oncology to Present Phase 1 SHARON Trial Results for BRCA/PALB2-Mutated Cancers at ESMO 2025

5 days ago2 min read

Key Insights

  • General Oncology will present preliminary Phase 1 results from the SHARON trial evaluating GO-4 therapy in patients with BRCA/PALB2-mutated pancreatic and breast cancers at ESMO 2025.

  • The GO-4 regimen combines melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous stem cell infusion as an Advanced Redox Modulation approach for metastatic cancers.

  • The Phase 1 study is designed to evaluate safety, feasibility, and preliminary efficacy in patients with advanced pancreatic ductal adenocarcinoma or breast cancer.

General Oncology 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, its patented Advanced Redox Modulation regimen, in patients with advanced pancreatic ductal adenocarcinoma or breast cancer harboring inherited BRCA/PALB2 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 in patients with advanced pancreatic or breast cancer. 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/PALB2 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 and an Inherited BRCA/PALB2 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's GO-4 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 and other proliferative diseases.

Company Focus on Metastatic Cancer Treatment

General Oncology positions itself as dedicated to pioneering first-in-class medicines for metastatic cancers. The company is currently completing the Phase 1 SHARON trial for metastatic cancers in the setting of BRCA1/2 or PALB2 mutations, with a stated commitment to advancing transformative therapies for cancer patients.
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