German biotech company Ariceum Therapeutics announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to start a Phase I/II clinical trial (SANTANA-225) of its proprietary radiolabelled peptide, 225Ac-SSO110, in patients with small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC).

A global, open-label Phase I/II study, SANTANA-225 is intended to evaluate the safety, tolerability, preliminary efficacy and recommended Phase II dose of 225Ac-SSO110 in patients with extensive-stage SCLC or MCC who are on first-line maintenance therapy with checkpoint inhibitors.

Ariceum Therapeutics is collaborating with its partners and clinical sites in the US and other countries to start recruitment of patients in the first quarter of 2025.

The product is being developed along with its companion patient selection tracer 68Ga-SSO120 as a 'theranostic pair' targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC and other aggressive cancers.