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

Recruiting Early Phase 1 Interventional Study
Thyroid Gland Anaplastic Carcinoma Poorly Differentiated Thyroid Carcinoma Cancer Head and Neck Cervix Carcinoma Vulvar Cancer, Stage IV Non-small Cell Lung Cancer Stage IV
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Karolinska University Hospital · Other
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About This Trial
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 a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant must be 18 years of age or older 2. Willing and able to provide written informed consent 3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pat…
Contacts

Renske Altena, Associate Professor, MD PhD

+46812375518

renske.altena@ki.se

CONTACT

Thuy Tran, Associate Prof, PharmD, PhD

+46727418988

thuy.tran@ki.se

CONTACT