Approximately 20% of patients with TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.
The multicenter, dose-expansion, Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing, TNBC (IHC 2+/3+).
This is the third cohort launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.
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 most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.
A recommended Phase 2 dose (RP2D) of 220 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 (NCT03094169) is an open label, multicenter, dose-expansion study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).
Source: Company Press Release