[177Lu]Lu-AKIR001 First-in-human Study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \[177Lu\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is: • What is the toxicity profile of the study drug \[177Lu\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \[177Lu\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.

Timeline

Start

2026-01-28

Primary completion

2027-11-01

Completion

2028-11-01

Publications

• Mortensen ACL, Mohajershojai T, Gustafsson A, Berglund H, Selvaraju RK, Hofstrom C, Persson H, Ohlin M, Tran TA, Moren AF, Ochniewicz P, Zedenius J, Bernhardt P, Frejd FY, Nestor M. Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials. J Nucl Med. 2026 Feb 2;67(2):269-275. doi: 10.2967/jnumed.125.270782.

Drugs

Indications