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Study identifier: NCT06639191 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Thyroid Gland Anaplastic Carcinoma · Poorly Differentiated Thyroid Carcinoma · Cancer Head and Neck  ·  Sponsor: Karolinska University Hospital

PhaseEARLY_Phase 1
Planned participants15
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Renske Altena, Associate Professor, MD PhD  ·  +46812375518  ·  renske.altena@ki.se

Thuy Tran, Associate Prof, PharmD, PhD  ·  +46727418988  ·  thuy.tran@ki.se

Always discuss trial participation with your own doctor first.

Locations (1)

Karolinska University hospitalStockholm, Stockholm County, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT06639191