Iovance Biotherapeutics (IOVA) said Monday that it has received clearance from the US Food and Drug Administration for its investigational new drug application for a phase 1/2 basket trial of IOV-5001 targeting solid tumors.

The trial will start enrolling patients in H2 to evaluate a one-time IOV-5001 regimen without IL-2 in advanced colorectal, triple-negative and estrogen receptor-low breast cancers, along with other solid tumors, Iovance Biotherapeutics said.

IOV-5001 is designed to improve on an earlier IL-12 tumor infiltrating lymphocyte therapy that showed a 63% objective response rate, the company said.