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April 24, 2019updated 12 Jul 2022 1:06pm

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.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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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.

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.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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