On March 7, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, reported that the first patient has been dosed in a Phase 2a squamous cell carcinoma of the head and neck (SCCHN) clinical trial (Press release, Forbius, MAR 7, 2019, View Source [SID1234534088]).
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The majority of SCCHN patients have tumors that overexpress epidermal growth factor receptor (EGFR) and approximately 20% have tumors that highly overexpress EGFR (more than 50% of cells with EGFR 3+ staining by a validated immunohistochemistry assay). No therapy is approved for the treatment of EGFR-overexpressing SCCHN.
The multicenter SCCHN trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with EGFR IHC 3+ tumors and follows the previously announced Phase 2a trial of AVID100 in patients with advanced squamous non-small cell lung cancer.
About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development.
A recommended Phase 2 dose (RP2D) of 240 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.
AVID100-01 is an open label, multicenter, dose-escalation study to evaluate the safety and efficacy of AVID100 in patients with confirmed EGFR-overexpressing tumors.