Switzerland-based Debiopharm International has started dosing patients in a Phase Ib clinical trial of Debio 1143 to treat advanced solid tumours.
Being conducted as part of the firm’s ongoing clinical collaboration with the Merck-Pfizer Alliance, the trial will involve combination of the investigational agent with avelumab.
Debio 1143 is a potent, orally available inhibitor of apoptosis proteins (IAP) with immunomodulatory properties. It has the ability to promote apoptosis of cancer cells by imitating the natural second mitochondrial-derived activator of caspases (SMAC).
The dual mechanism of action of Debio 1143 is expected to improve treatment outcomes in cancer patients administered with a combination of immunotherapy, chemotherapy and/or radiotherapy.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody with the potential to leverage adaptive and innate immune systems.
The multi-centre, dose-finding, open-label Phase Ib trial will evaluate the safety and potential efficacy of the combination therapy in patients who did not receive previous immunotherapy.
An adaptive dose-escalation part of the trial designed to find a recommended Phase II dose of Debio 1143 in combination with a standard avelumab dose will be followed by an expansion part, including 37 subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Debiopharm International Oncology medical director Sergio Szyldergemajn said: “We are very excited to conduct this Phase Ib study to evaluate the potential of combining our Debio 1143 molecule with avelumab.
“This is the first time this combination is being investigated in patients and we are looking forward to assessing the therapeutic potential of our compound in the immuno-oncology space.”
Merck and Pfizer formed a partnership to co-develop and co-commercialise avelumab in 2014, while Debiopharm signed the collaboration agreement with the Merck-Pfizer Alliance last year.