A first‐in‐class, first‐in‐human, phase I trial of CIGB ‐552, a synthetic peptide targeting COMMD1 to inhibit the oncogenic activity of NF‐κB in patients with advanced solid tumors

CIGB-552 is a synthetic peptide that interacts with COMMD1 and upregulates its protein levels. The objectives of this phase I study were safety, pharmacokinetic profile, evaluation the lymphocytes CD4+ CD8+ preliminary activity in patients advanced tumors. A 3 + dose-escalation design seven dose levels was implemented. Patients included until grade related adverse event occurred maximum tolerated reached. received subcutaneous administration three times per week for 2 weeks. Single-dose plasma pharmacokinetics characterized at two levels, tumor responses classified by RECIST 1.1. Twenty-four CIGB-552. Dose-limiting toxicity associated transient pruritic maculopapular rash 7.0 mg. defined as 4.7 Ten assessable immunological status. Seven had significant changes ratio CD4/CD8 response to treatment; did not modify Stable disease observed five patients, including metastatic soft sarcomas. We conclude mg well no events appeared provide some clinical benefits.