DrugCendR has started the Phase l CEND1-001 trial to examine the safety, tolerability, and biologic activity of CEND-1 in combination with nabpaclitaxel and gemcitabine to treat patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
The open-label, multicentre, dose-escalation, safety, pharmacodynamic, and pharmacokinetic trial intends to enrol 34 PDAC patients being treated with combination therapy of nabpaclitaxel and gemcitabine.
As part of the trial, the patients will receive the study combination weekly for three weeks followed by one week off over 28 days.
The trial will include an initial dose-escalation phase with three different CEND-1 dose levels, first as a monotherapy, which will be followed by combination therapy with nabpaclitaxel and gemcitabine.
It will also feature a subsequent expansion phase with around 28 subjects to evaluate the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels.
Primary endpoints of the CEND1-001 trial are safe doses of CEND-1 when given alone or in combination with nabpaclitaxel and gemcitabine, and optimal Biological Dose (OBD) of CEND-1 when administered in combination.
The trial’s secondary endpoints include pharmacokinetics, disease control rate, preliminary evidence of anti-tumour activity of CEND-1 and others.
DrugCendR founder, president and CEO Erkki Ruoslahti said: “Cancer cells hijack processes they can use to fuel tumour growth, and the CendR pathway is one such route.
“CEND-1 activates the CendR pathway only in tumours and not elsewhere in the body, and that allows us to sneak in a drug into the activated pathway.”
Ruoslahti discovered CEND-1, a peptide that homes in on tumours using a multi-step process, at his laboratory at Sanford Burnham Prebys Medical Discovery Institute (SBP) in the US.