Forbius has dosed the first patient in a Phase IIa triple negative breast cancer (TNBC) clinical trial to evaluate the safety and efficacy of AVID100.
AVID100 is a novel, tumour-selective anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC).
For the multi-centre, dose-expansion Phase IIa trial (AVID100-01; NCT03094169), the efficacy, safety, and tolerability of AVID100 will be assessed in patients with advanced, EGFR-overexpressing TNBC (IHC 2+/3+).
Forbius noted that this is the third cohort that has been launched. It follows earlier cohorts evaluating AVID100 to treat patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN).
A total of about 100 patients will be evaluated across sqNSCLC, SCCHN, and TNBC, the three EGFR-overexpressing tumour types, as part of the trial.
The highly potent EGFR-targeting ADC, AVID100, has been engineered to achieve enhanced anti-tumour efficacy without a corresponding increase in toxicity in skin or other EGFR-expressing normal tissues.
A recommended Phase II dose (RP2D) of 220mg/m2 (~6mg/kg) was established for AVID100 in a Phase I study that was completed.
The RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies.
It was found that the majority of treatment-related adverse events in the Phase I trial at the RP2D were well-tolerated.
AVID100-01 is an open-label, multi-centre, 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+).
About 20% of TNBC patients have tumours that highly overexpress EGFR.