The Phase I clinical trials are open-label, dose escalation studies of SGX523 administered orally to patients with advanced cancer who have either failed standard therapy or for whom no standard therapy exists. The studies are designed to explore two dosing regimens in parallel. The continuous dosing trial will have continuous uninterrupted twice daily dosing with patients being evaluated every 28 days for continuation of treatment. The intermittent dosing schedule will implement twice daily dosing on a 14 days on/7 days off therapy schedule, cycling every 21 days. In both protocols, patients may continue on therapy for up to 12 months as determined by the patient’s response and tolerance to SGX523.
The Phase I studies are designed to evaluate the safety, tolerability and pharmacokinetic profile of SGX523, an internally developed, orally-bioavailable, small molecule inhibitor of the cMET receptor tyrosine kinase.
Mike Grey, president and CEO of SGX Pharmaceuticals, said: “With two separate dosing schedules, we believe that we will be able to collect important data that could serve as a basis for future clinical development activities and position us to capitalize on the evolving cMET opportunity.”