Nordic Nanovector has dosed the first patient in its Phase Ib Archer-1 trial evaluating the safety and preliminary activity of betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) for the treatment of patients with second-line follicular lymphoma (2L FL).
FL is a type of blood cancer and the most common of the indolent non-Hodgkin's lymphomas.
As part of the open-label, single-arm, multi-centre trial, Nordic Nanovector aims to enrol 20-25 patients with relapsed / refractory FL who have received one or more prior therapies.
Patients will initially be treated with 10MBq/kg betalutin and 40mg lilotomab, with increased doses expected in the future.
After the betalutin dosing, patients will get four weekly doses of 375mg/m2 RTX.
The primary objective of the dose-escalation trial is safety, while secondary objectives comprise overall response rate, duration of response, progression-free survival and overall survival.
Nordic Nanovector CEO Eduardo Bravo said: “Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients.
“If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL.”
Betalutin is an anti-CD37 antibody (lilotomab) designed to target tumours.
The solution demonstrated improved efficacy and safety in the first part of the Phase I/II LYMRIT 37-01 clinical trial in relapsed / refractory follicular lymphoma (R/R FL).
RTX is developed to target CD20. The monoclonal antibody is used to treat patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy.