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

A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours

NCT06639191•Karolinska University Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during/after available standard of care treatment options as mentioned below:
•* For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):
•* For BRAFv600E mutated tumours: BRAF/MEK inhibitors.
•* For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy/ chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)
•* For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)
•* For HNSCC:
•\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \<1 (or if immunotherapy is contraindicated)
•* For NSCLC
+20 more criteria

Exclusion Criteria

•1. Symptomatic brain metastases that are not previously treated and/or that require ongoing steroid-treatment
•2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
•3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.
•4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \> 1 from previous anti-cancer treatments.
•5. Pregnancy or lactation
•6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical/ psychiatric disorders.
•7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.
•8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.

Locations (1)

Karolinska University hospital

Stockholm, Stockholm County, Sweden

Key Dates

Start Date

January 28, 2026

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2028

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Thyroid Gland Anaplastic CarcinomaPoorly Differentiated Thyroid CarcinomaCancer Head and NeckCervix CarcinomaVulvar Cancer, Stage IVNon-small Cell Lung Cancer Stage IV

Interventions

[177Lu]Lu-AKIR001

DRUG

Contacts

Renske Altena, Associate Professor, MD PhD

CONTACT

+46812375518 renske.altena@ki.se

Thuy Tran, Associate Prof, PharmD, PhD

CONTACT

+46727418988 thuy.tran@ki.se

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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