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news.Symphogen has initiated a Phase 1/2 human clinical trial in the US to evaluate the safety, tolerability and efficacy of its drug candidate Sym004 for the treatment of advanced solid tumors.
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Sym004 is composed of two anti-epidermal growth factor receptor (EGFR) monoclonal antibodies targeting different nonoverlapping EGFR epitopes.
Symphogen said that the Phase 1/2 clinical trial is an open-label, multi-center dose escalation trial study to evaluate the safety and tolerability of Sym004 of multiple doses of Sym004 in patients with advanced solid tumors.
The first part of the trial is being conducted at the South Texas Accelerated Research Therapeutics (START) Clinic, San Antonio, Texas and Vall d’Hebron University Hospital in Barcelona, Spain.
Reportedly, the trial consists of two parts; in both parts, Sym004 will be administered intravenously once weekly. In Part A, Sym004 will be studied in a heterogeneous population of patients with refractory or recurrent advanced solid tumors and late stage cancer.
However, in Part B, which is a Phase 2 extension of the trial, the maximum tolerated dose is expected to be studied in patients with refractory or recurrent advanced metastatic colorectal cancer and the wild type form of the KRAS protein. The presence of wild type KRAS is known to be predictive of response for other anti-EGFR targeted therapeutics.
In the trial, the secondary endpoints will include an evaluation of objective tumor response, duration of overall response, progression free survival, overall survival, immune response, skin rash and biomarkers.
Kirsten Drejer, CEO of Symphogen, said: “The preclinical results that were recently published in Cancer Research hold great promise for Sym004 and we are very excited about advancing this compound into the clinic.
“Sym004’s novel mechanism of action appears to exhibit anti-cancer effects on EGFR-resistant tumors. EGFR, which is a proven and attractive therapeutic target, represents a potential multi-billion dollar market opportunity. We look forward to reporting data from Part A of this trial in early 2011 and continuing to advance Sym004 into a Phase 2 extension of the trial as quickly as possible.”