No safety signals have been observed, and the trial is now proceeding to the next stage as planned.
The trial is being conducted at Karolinska University Hospital, which also serves as the study sponsor.
The aim is to evaluate safety, tolerability, and pharmacokinetics in patients with advanced, difficult-to-treat solid tumours.
Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumour types — with the therapeutic radioisotope lutetium-177.
Through this mechanism, radiation can be delivered directly to tumour cells while minimising impact on surrounding healthy tissue.
All patients planned for the first dose cohort have now been enrolled. No dose-limiting toxicities or other safety concerns have been observed.
“Completing the first cohort marks an important milestone for AKIR001. Our goal is to develop a treatment that reaches tumours with high selectivity and has a favourable safety profile. These initial clinical data support the next step in development,” says Marika Nestor, CEO of Akiram Therapeutics.
“The completion of cohort 1 without unexpected side effects represents an important step forward. The results suggest that the drug is well tolerated at the doses tested so far, and we are pleased to proceed as planned,” says Dr Luigi De Petris, Principal Investigator at Karolinska University Hospital.
The trial is enrolling patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynaecological squamous cell carcinoma and non-small cell lung cancer.
In the next phase, additional patients will be included to gather further data on dose response, safety, and early signs of efficacy.