Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
April 24, 2019

Forbius doses first patient in Phase IIa trial of AVID100

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.

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, 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.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU