Actively Recruiting
[177Lu]Lu-AKIR001 First-in-human Study
Led by Karolinska University Hospital · Updated on 2026-01-30
15
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
K
Karolinska University Hospital
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
[177Lu]Lu-AKIR001 First-in-human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older
- Willing and able to provide written informed consent
- Have histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing solid malignancy in specified cancer groups
- Documented disease progression in the last 8 weeks during or after available standard treatments
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least three months
- Adequate organ and bone marrow function within 8 days before first infusion
- Females of child-bearing potential must agree to use effective contraception during and for 6 months after treatment
- Male participants must agree to use effective barrier contraception or abstain from heterosexual intercourse during treatment and for 4 months after last dose
You will not qualify if you...
- Symptomatic brain metastases not treated or requiring ongoing steroid treatment
- Other malignancy diagnosed within last 5 years except certain skin or cervical cancers
- Chemo, targeted or radiotherapy within last 4 weeks before study enrollment
- Ongoing toxicities greater than grade 1 from previous cancer treatments
- Pregnancy or lactation
- Uncontrolled hypertension, heart, liver, or kidney disease, or other medical/psychiatric disorders
- Severe skin diseases requiring systemic anti-inflammatory treatment
- Known HIV, hepatitis B or C infection, or active tuberculosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University hospital
Stockholm, Stockholm County, Sweden, 17176
Actively Recruiting
Research Team
R
Renske Altena, Associate Professor, MD PhD
CONTACT
T
Thuy Tran, Associate Prof, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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