Galera Therapeutics has dosed the first patient in a Phase I/II clinical trial of GC4419 for the treatment of locally advanced pancreatic cancer (LAPC).
Dosing was conducted at The University of Texas MD Anderson Cancer Centre in Houston, Texas, US.
The adaptive, dose escalation trial is aimed at evaluating the safety and anti-tumour effect of GC4419 in combination with stereotactic body radiation therapy (SBRT), compared with SBRT alone, in LAPC patients.
A total of 48 patients will be included in the trial, which will also evaluate safety and tolerability to establish the maximum tolerated dose of SBRT when combined with GC4419 or placebo.
Galera Therapeutics president and CEO Mel Sorensen said: “Our recently completed 223-patient Phase IIb trial of GC4419 in head and neck cancer demonstrated GC4419’s ability to limit radiation-induced healthy tissue damage by reducing the duration, incidence and severity of radiation and chemotherapy-induced oral mucositis.
“We seek to build upon these results with this anti-tumour trial in LAPC and generate robust data to demonstrate GC4419’s potential to change the management of radiation therapy by both protecting normal tissue and improving the effectiveness of radiation, making more surgical resections possible.”
In addition, preclinical data have showed GC4419’s potential to enhance the effectiveness of radiation on cancer cells while preventing toxicity in normal tissue.
GC4419 leverages Galera’s dismutase mimetic platform to rapidly turn the superoxide produced by radiation therapy into hydrogen peroxide, which is fatal to cancer cells in high concentrations.
The drug previously received breakthrough therapy designation from the US Food and Drug Administration (FDA) for reducing the duration, incidence, and severity of severe oral mucositis (SOM) induced by radiation therapy with or without systemic therapy.