Ascelia Pharma AB (STO:ACE), a biotech company focused on orphan oncology treatments, announced on Tuesday the clinical development plan for Oncoral, a daily tablet formulation of irinotecan developed initially for the treatment of gastric cancer.

Irinotecan is a well-established chemotherapy that is already approved for treating colorectal and pancreatic cancer as well as for gastric cancer in Japan.

The planned Phase 2 study for the treatment of gastric cancer will examine Oncoral added to standard of care, compared to standard of care alone. The primary endpoint will be progression-free survival, with secondary endpoints including response rate, overall survival, pharmacokinetics, safety and tolerability.

The study is expected to start in the second half of 2021.

For subsequent development, there is potential for label expansion into other solid tumour indications where irinotecan has also proved efficacious, Ascelia Pharma said.