Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials.
Anja C L Mortensen, Tabassom Mohajershojai, Amanda Gustafsson...
https://pubmed.ncbi.nlm.nih.gov/41198237/Actively Recruiting
Led by Karolinska University Hospital · Updated on 2026-01-30
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying the safety and tolerability of increasing doses of 177LuLu-AKIR001, a drug targeting CD44v6-expressing solid tumors that cannot be surgically removed or have spread. This early phase 1 trial focuses on patients with advanced cancers such as thyroid gland anaplastic carcinoma, poorly differentiated thyroid carcinoma, head and neck cancer, cervix carcinoma, vulvar cancer stage IV, and non-small cell lung cancer stage IV, who have no other reasonable treatment options. The main goal is to understand the toxicity profile of 177LuLu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.
CONDITIONS
[177Lu]Lu-AKIR001 First-in-human Study
R
Renske Altena, Associate Professor, MD PhD
T
Thuy Tran, Associate Prof, PharmD, PhD
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Karolinska University Hospital
Lead Sponsor
Karolinska Institutet
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 6 weeks post-dose per cohort
Participants receive escalating doses of [177Lu]Lu-AKIR001 according to cohort assignment to evaluate safety and tolerability.
1 baseline visit and weekly visits during 6-week follow-up
Duration - Up to 12 months for efficacy and up to 5 years for safety
Participants are monitored for long-term safety, anti-tumor efficacy, and adverse events.
Periodic visits over 12 months and annual visits up to 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Anja C L Mortensen, Tabassom Mohajershojai, Amanda Gustafsson...
https://pubmed.ncbi.nlm.nih.gov/41198237/Karolinska University Hospital
Lead Sponsor
Karolinska Institutet
Collaborating Sponsor