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/41198237Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID06639191
A Phase 1 Study to Evaluate Safety, Tolerability, and Biodistribution of [177Lu]Lu-AKIR001 in Adults With CD44v6 Expressing Solid Tumors
Led by Karolinska University Hospital · Updated on 2026-01-30
15
Participants Needed
1
Research Sites
52 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
Researchers are studying the safety and tolerability of increasing doses of [177Lu]Lu-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 [177Lu]Lu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.
CONDITIONS
Brief Title
[177Lu]Lu-AKIR001 First-in-human Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older
- Able and willing to provide written informed consent
- Has histologically confirmed metastatic or locally advanced irresectable CD44v6-expressing solid malignancy with disease progression in the last 8 weeks
- Specific prior treatments depending on tumor type, including targeted therapies or chemotherapy as detailed in protocol
- Measurable disease per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least three months as estimated by investigator
- Adequate organ and bone marrow function within 8 days before first infusion
- Females of childbearing potential must use effective contraception before, during, and for 6 months after treatment
- Male participants must use effective barrier contraception or abstain from heterosexual intercourse during treatment and for 4 months after last dose
You will not qualify if you...
- Untreated or symptomatic brain metastases requiring ongoing steroids
- Other malignancies diagnosed within last 5 years except certain skin or cervical cancers
- Chemotherapy, targeted therapy, or radiotherapy within 4 weeks prior to enrollment
- Ongoing toxicities greater than grade 1 from previous cancer treatments
- Pregnancy or breastfeeding
- Uncontrolled hypertension, heart, liver, or kidney disease or other serious medical or psychiatric conditions
- Severe skin diseases requiring systemic anti-inflammatory treatment
- Known HIV infection, hepatitis B or C infection, or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
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
Trial Site Locations
Total: 1 location
1
Karolinska University hospital
Stockholm, Stockholm County, Sweden, 17176
Actively Recruiting
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Research Team
R
Renske Altena, Associate Professor, MD PhD
T
Thuy Tran, Associate Prof, PharmD, PhD
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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