Clinical Development

Along with a comprehensive biomarker program, amcure has started a two part Phase I/Ib trial for AMC303 in October 2016. The trial, conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin. In the first part, the dose escalation, the study design included a broad variety of tumor types irrespective of the target expression. In the second part, the expansion cohort, amcure focuses its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors The first part of the clinical study, the dose escalation study, has already been successfully completed and confirmed the safety and tolerability of AMC303.

Phase I/Ib – Part 1 (completed)

The dose escalation study with a 3+3 design investigated safety, tolerability and pharmacokinetics of AMC303 at a dose of 0.1-20 mg/kg twice weekly. The all-comer study included a broad variety of tumor types irrespective of the target expression.

No drug-related serious adverse events were reported from the 27 patients in the dose escalation study. The most frequent adverse events were of grade 1 and 2 and could be well managed in the clinic.

Phase I/Ib – Part 2 (ongoing)

Since AMC303 was proven to be safe and well tolerated up to 20 mg/kg, Phase Ib of the clinical trial was initiated with the recommended dose of 10 mg/kg (RP2D). The four tumor types with the highest CD44v6 expression, head and neck squamous cell carcinoma (HNSCC), esophageal and cervical carcinoma, and non-small-cell lung carcinoma (NSCLC) were chosen for this study. The ongoing expansion cohort will enroll up to 28 patients, 7 per indication, with confirmed expression of CD44v6. Tumors will be assessed (RECIST) every 8 weeks and mandatory paired biopsies will be performed in 60% of the patients.

For more information on the trial design, please visit: https://clinicaltrials.gov/ct2/show/NCT03009214?term=amcure&recrs=a&rank=1