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).

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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, as part of the trial.”

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.

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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.