Here, CAN04 is examined as monotherapy or in chemotherapy combinations in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer (PDAC). All 20 patients planned for one of these arms, monotherapy, have now started treatment at 10 mg/kg. Overall, the safety has been good and in line with the results from phase I.
The monotherapy results including biomarkers and efficacy are estimated to be ready during Q4 2019. On the back of rapid recruitment and good safety, Cantargia plan to use the opportunity to include additional patients to generate safety and biomarker data at a higher dose level. In parallel to the monotherapy, recruitment is ongoing for the combination arms.
Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling.
Approximately 80 % of patients with NSCLC and 70 % of patients with PDAC overexpress IL1RAP on their cancer cells and in these diseases all patients have IL1RAP containing cells in the tumor microenvironment.
CAN04 is investigated in an open label three-armed phase I/IIa clinical trial, CANFOUR, examining monotherapy as well as combination with two different standard chemotherapy regimes in patients with NSCLC or PDAC (www.clinicaltrials.gov). The study is designed for 20 patients in monotherapy and approximately 30 patients in each combination arm.
Twenty patients (6 NSCLC and 14 PDAC) in the phase IIa monotherapy arm have now started treatment with CAN04 at 10 mg/kg. The safety profile has been very good and in line with the results from phase I. Tumor biopsies, taken before and during therapy, have been obtained from most patients in the trial.
Analysis of these biopsies will provide an opportunity to study the impact of CAN04 in the tumor microenvironment. Biomarkers will also be analyzed in the serum. It is estimated that the results of these analyses can be reported during Q4 2019 together with efficacy results obtained from CT-scans.
The recruitment to the monotherapy arm has gone more rapid than planned. To take advantage of the rapid recruitment and the good safety of CAN04, up to 12 additional patients are planned to be included to investigate safety and biomarkers at a higher dose level, 15 mg/kg. The recommended phase II dose is 10 mg/kg , and documenting safety at higher dose levels provides long term advantages e.g. regarding safety margins.
Recruitment is also ongoing in the combination arms of the CANFOUR study. The trial includes a dose escalation strategy in the first group of patients, using a 3+3 design. The dose escalation phase is ongoing and results from the combination arms are estimated to be presented early 2020, as previously communicated.
“We are excited about the progress in the CANFOUR trial. It is very encouraging that safety continue be good and supports studies in patients at a higher dose level to obtain additional valuable information on safety and biomarkers”, Göran Forsberg, Cantargia’s CEO says.
Source: Company Press Release