Actively Recruiting
A Phase 1 Study to Evaluate Safety, Tolerability, and Biodistribution of 177LuLu-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 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
Brief Title
[177Lu]Lu-AKIR001 First-in-human Study
Who Can Participate
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
Research Team
R
Renske Altena, Associate Professor, MD PhD
T
Thuy Tran, Associate Prof, PharmD, PhD
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