The pTTL clinical development program starts with the open label Phase Ib/IIa First-In-Human Study evaluating pTTL as monotherapy in patients with locally advanced or metastatic solid cancer. The study will be initiated in 2021. Study population is cancer type-agnostic with an emphasis on patients with colorectal cancer (CRC).
Primary objective with this study is safety. Efficacy is a secondary objective, which will be concurrently evaluated throughout this open label study.
Following results from the open label safety study we expect to be able to extrapolate safety, tolerability as well as dose across other types of solid tumours. In the current outline we will focus on CRC as the main track to fast marketing authorisation. Orphan indications, such as mesothelioma are being evaluated in parallel for a possibility of an orphan track to be included.
pTTL contains the patient’s own T-lymphocytes boosted for activity towards the tumor and is not expected to cause significant side effects. This is of great advantage as it would make pTTL a prime candidate for combination therapy to further enhance anti-tumour efficacy.