Corvus Pharmaceuticals is set to enrol patients in a Phase I/Ib clinical trial of CPI-006 in combination with CPI-444 and pembrolizumab for the treatment of various solid tumours.
The three-arm, dose-selection trial expects to select the dose as well as analyse the safety, pharmacokinetics, immune biomarkers and efficacy of CPI-006 as a single agent in combination with CPI-444 and pembrolizumab.
It will enrol patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC ), and other cancers who have failed standard therapies.
The trial’s efficacy endpoints include complete response (CR), partial response (PR), disease control rate, duration of response, progression-free survival and overall survival.
Under the trial’s dose-selection part, doses of CPI-006 will be increased in the single-agent arm and in the two combination arms to identify the maximally tolerated dose, or the dose that saturates the CD73 enzyme.
It will use fixed doses of CPI-444 and pembrolizumab.
Following the determination of an optimum dose of CPI-006, Corvus will begin enrolment for the second part of the trial that will include patients in nine cohorts.
Three of the nine patient cohorts will receive CPI-006 alone, while three will receive CPI-006 in combination with CPI-444, and another three will receive CPI-006 with pembrolizumab.
Each of the three disease-specific arms of the trial will include patients with NSCLC, RCC and other groups of cancers. Initially, up to 11 patients are expected to be enrolled in each of the nine cohorts.
Depending upon the existence of one or more objective responses (CR or PR) in the 11 patients, the cohort may be expanded to include 28 patients. The trial could enrol a total of 350 patients.
Corvus CEO Richard A Miller said: “CPI-006 is an antibody engineered to completely inhibit the CD73 enzyme by binding to its active site. We look forward to evaluating this anti-CD73 antibody in our comprehensive Phase I/Ib trial, which we believe is the first human clinical trial in oncology to evaluate the effect of dual-blockade of the adenosine pathway by inhibiting both CD73 and the A2A receptor.
“This trial is designed to answer multiple important questions regarding the role of CD73 blockade and the adenosine pathway in patients with advanced cancer.”