NCT06639191 (AKIR001) is a EARLY_PHASE1 clinical trial of [177Lu]Lu-AKIR001 in Thyroid Gland Anaplastic Carcinoma, sponsored by Karolinska University Hospital.

Who is sponsoring NCT06639191?

NCT06639191 is sponsored by Karolinska University Hospital.

What drugs are being tested in NCT06639191?

Interventions in NCT06639191: [177Lu]Lu-AKIR001.

What condition does NCT06639191 study?

NCT06639191 studies 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.

Is NCT06639191 still recruiting?

NCT06639191 is currently recruiting now. Last updated 30 January 2026.

Last reviewed 2026-01-30 · How we verify

NCT06639191: AKIR001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now EARLY_PHASE1 Last updated 30 January 2026

What this trial tests

EARLY_PHASE1 trial testing [177Lu]Lu-AKIR001 in Thyroid Gland Anaplastic Carcinoma in 15 participants. Currently enrolling.

Timeline

28 January 2026

Primary endpoint
1 November 2027

1 November 2028

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	28 January 2026
Primary completion	1 November 2027
Estimated completion	1 November 2028
Sites	1 location across Sweden

Drugs / interventions tested

[177Lu]Lu-AKIR001 — full drug profile →

Conditions studied

Thyroid Gland Anaplastic Carcinoma — all drugs for Thyroid Gland Anaplastic Carcinoma →
Poorly Differentiated Thyroid Carcinoma — all drugs for Poorly Differentiated Thyroid Carcinoma →
Cancer Head and Neck — all drugs for Cancer Head and Neck →
Cervix Carcinoma — all drugs for Cervix Carcinoma →

Sponsor

Karolinska University Hospital

Who can join

18 and older, any sex, with Thyroid Gland Anaplastic Carcinoma or Poorly Differentiated Thyroid Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Preclinical Validation of [<sup>177</sup>Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials.
Mortensen ACL, Mohajershojai T, Gustafsson A, Berglund H, et al · · 2026 · cited 1× · PMID 41198237 · DOI 10.2967/jnumed.125.270782
CD44v6 expression in non-anaplastic thyroid carcinoma: characterization of candidates for targeted therapy.
Stenman A, Nilsson JN, Condello V, L Mortensen AC, et al · · 2025 · cited 1× · PMID 41039489 · DOI 10.1186/s13044-025-00266-3
Emerging Immunotherapy and Antibody-Derived Therapeutics for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Review.
Hou AY, Elantably D, Manochakian R, Velcheti V, et al · · 2026 · PMID 42073614 · DOI 10.3390/cancers18081291

Verify or expand the search:

Other recruiting trials for Thyroid Gland Anaplastic Carcinoma

Currently open trials in the same condition.

NCT04675710 — Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer · Phase 2 · active not recruiting
NCT04759911 — Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer · Phase 2 · active not recruiting
NCT03975231 — Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer · Phase 1 · recruiting
NCT03449108 — LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC · Phase 2 · active not recruiting
NCT03181100 — Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer · Phase 2 · active not recruiting

Other Karolinska University Hospital trials

Trials by the same sponsor.

NCT07424690 — Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation · NA · not yet recruiting
NCT03629977 — Timing of Renal Replacement Therapy in the Critically Ill Patients · recruiting
NCT06983197 — Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy · not yet recruiting
NCT06835816 — Amino Acid Supplementation in Continuous Renal Replacement Therapy · NA · recruiting
NCT06791317 — Intubation Checklist in the Intensive Care Unit · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06639191 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Karolinska University Hospital
Last refreshed: 30 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06639191.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing