Thyroid Gland Anaplastic CarcinomaEarly Phase 1AKIR001NCT06639191
[177Lu]Lu-AKIR001 First-in-human Study
A Early Phase 1 study testing [177Lu]Lu-AKIR001 in people with Thyroid Gland Anaplastic Carcinoma and Poorly Differentiated Thyroid Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Gland Anaplastic Carcinoma, Poorly Differentiated Thyroid Carcinoma, Cancer Head and Neck
- What is being tested?
- [177Lu]Lu-AKIR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 28 Jan 2026to 1 Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years of age or older
- Willing and able to provide written informed consent
- 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)
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- 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
- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.
- For vulvar SCC:
- After treatment with first line platinum/paclitaxel+/-bevacizumab +/- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel
- For cervical SCC:
- After treatment with first line systemic therapy with platinum/paclitaxel+/-pembrolizumab (the latter in case of PD-L1 positivity)
- Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of at least three months as estimated by the investigator.
- Adequate organ and bone marrow function within eight days before the first [177Lu]Lu-AKIR001 infusion:
- Peripheral white blood cells (WBC) ≥3.0 x 109/L
- Absolute neutrophil count (ANC) ≥ 2,000/mm3
- Platelet > 100 x 109/L
- Hemoglobin > 100 g/L.
- Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL/min/1.73 m2 by Cockcroft- Gault
- Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)
- Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)
- Left Ventricular Ejection Fraction >50% on echocardiography
- Contraceptives
- Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and/or surgically sterile), she must have a documented negative serum pregnancy test before any [177Lu]Lu-AKIR001 infusion.
- Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.
Who cannot join
- Symptomatic brain metastases that are not previously treated and/or that require ongoing steroid-treatment
- 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
- Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.
- Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) > 1 from previous anti-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, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.
- A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University hospital
Stockholm, Stockholm County, 17176
Johanna Uggla, research nurse, johanna.uggla@regionstockholm.se
About this study
Official title: 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
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
- 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
- Being tested
- [177Lu]Lu-AKIR001
- Keywords
- Radiopharmaceutical, first-in-human, CD44v6, Lutetium-177, 177Lu-AKIR001
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-AKIR001Drug
Patient cohorts of a minimum of three and a maximum of 12 evaluable participants will be opened according to the decision tree defined in the protocol and will be consecutively completed. When one cohort has been completed and fully evaluated, the next cohort will be opened after all participants in the previous cohort have received at least one dose of the IMP without dose-limiting toxicities during a follow-up period of at least six weeks.
The [177Lu]Lu-AKIR001 protein mass dose and activity are predefined for each cohort, and could be adjusted according to the results of previous cohort(s) to ensure the safety of participants. The initial design of the trial encompasses five cohorts to escalate both [177Lu]Lu-AKIR001 pmd, from 50 mg to 100 mg, and activity, from 0.75 to 3.0 GBq.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm trial where patients are included in successive cohorts | Experimental | In the successive cohorts, increasing doses of radioactivity (177-Lu) and CD44v6-targeted antibody (AKIR001) are given. A new dose cohort is opened only when toxicity in the previous dose cohort has deemed acceptable by the trial steering committee and the independent Data Safety Monitoring Board. Receives: Drug: [177Lu]Lu-AKIR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - rate of dose limiting toxicities
- Rate of Dose Limiting Toxicities, according to the definition of (S)AEs according to the CTCAE version 5.0.
- TEAEs, SAEs, clinically significant laboratory abnormalities and deaths
- AEs ≥ grade 3 according to the CTCAE version 5.0 grading system (CTCAE v 5.0, 2017) during the treatment period
Measured: From first dose to a minimum of 6 weeks post-dose.
Secondary outcomes (9)
Biodistribution of 177Lu-AKIR001 in major organs and tissues
Uptake and elimination of the IMP from major organs and tissues will be assessed in % injected dose according to dosimetry
Measured: 8 days
Biodistribution of 177Lu-AKIR001 in the whole body
Elimination from whole body will be assessed in % injected dose according to dosimetry
Measured: 8 days
Pharmacokinetics of 177-Lu and AKIR001 in major organs
Blood concentration levels of lutetium-177 (Bq/mL) at different timepoints after [177Lu]Lu-AKIR001 infusion
Measured: 29 days
Recommended Phase 2 Dose
- The MTA (GBq) per infusion is defined as the highest tolerated administered activity of the IMP, below which <34% of participants experience DLT.
- The MTCA is defined as the highest tolerated cumulative activity of the IMP over all treatments, below which <34% of participants experience DLT.
Measured: From first dose to a minimum of 6 weeks post-dose.
Anti-tumor efficacy: radiological response
- CR, PR or SD counts after completion of at least one infusion of [177Lu]Lu-AKIR001, as assessed by RECIST v1.1.
Measured: 12 months
Long-term occurrence of adverse events
Long-term related AEs and AEs of interest in each cohort; a 5-year long-term safety period will start after first [177Lu]Lu-AKIR001 infusion.
Measured: 5 years
Dosimetry of 177Lu-AKIR001
- Absorbed dose per administered activity (Gy/GBq) per organ and selected tumour lesions
Measured: 8 days
Anti-tumor efficacy: overall response rate
- ORR based on the endpoints CR or PR according to RECIST v1.1.
Measured: 12 months
Antitumor efficacy: duration of response
DoR, defined as the time from initial response (CR or PR) until the time of progression according to RECIST v1.1.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start28 Jan 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Gland Anaplastic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a prospective, open-label, first-in-human Phase 1 dose-finding trial. Patients will be included in consective dosing cohorts, with both increasing doses of radioactivitity (Lutetium-177) and the CD44v6-targeted antibody (AKIR001)
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University
- Responsible party
- Principal investigator, Renske Altena, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639191
- Sponsor's protocol ID
- AKIR001
- Other IDs
- 2023-508126-95-00, 2023
- Acronym
- AKIR001
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mortensen ACL, Mohajershojai T, Gustafsson A, Berglund H, Selvaraju RK, Hofstrom C, Persson H, Ohlin M, Tran TA, Moren AF, Ochniewicz P, Zedenius J, Bernhardt P, Frejd FY, Nestor M. Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials. J Nucl Med. 2026 Feb 2;67(2):269-275. doi: 10.2967/jnumed.125.270782.
PubMed 41198237
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06639191
- Acronym / sponsor ID
- AKIR001 / AKIR001
- Conditions
- 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
- Keywords
- Radiopharmaceutical, first-in-human, CD44v6, Lutetium-177, 177Lu-AKIR001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, open-label, first-in-human Phase 1 dose-finding trial. Patients will be included in consective dosing cohorts, with both increasing doses of radioactivitity (Lutetium-177) and the CD44v6-targeted antibody (AKIR001)
| Arm | Type | Receives |
|---|---|---|
| This is a single arm trial where patients are included in successive cohorts | Experimental | Drug: [177Lu]Lu-AKIR001In the successive cohorts, increasing doses of radioactivity (177-Lu) and CD44v6-targeted antibody (AKIR001) are given. A new dose cohort is opened only when toxicity in the previous dose cohort has deemed acceptable by the trial steering committee and the independent Data Safety Monitoring Board. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Participant must be 18 years of age or older
- Willing and able to provide written informed consent
- 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:
- Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (8 listed)
- Symptomatic brain metastases that are not previously treated and/or that require ongoing steroid-treatment
- 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
- Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.
- Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) > 1 from previous anti-cancer treatments.
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177Lu]Lu-AKIR001Patient cohorts of a minimum of three and a maximum of 12 evaluable participants will be opened according to the decision tree defined in the protocol and will be consecutively completed. When one cohort has been completed and fully evaluated, the next cohort will be opened after all participants in the previous cohort have received at least one dose of the IMP without dose-limiting toxicities during a follow-up period of at least six weeks. The [177Lu]Lu-AKIR001 protein mass dose and activity are predefined for each cohort, and could be adjusted according to the results of previous cohort(s) to ensure the safety of participants. The initial design of the trial encompasses five cohorts to escalate both [177Lu]Lu-AKIR001 pmd, from 50 mg to 100 mg, and activity, from 0.75 to 3.0 GBq. | Drug | This is a single arm trial where patients are included in successive cohorts |
Primary outcome
Primary Endpoint - rate of dose limiting toxicities
Time frame: From first dose to a minimum of 6 weeks post-dose.
1. Rate of Dose Limiting Toxicities, according to the definition of (S)AEs according to the CTCAE version 5.0. 2. TEAEs, SAEs, clinically significant laboratory abnormalities and deaths 3. AEs ≥ grade 3 according to the CTCAE version 5.0 grading system (CTCAE v 5.0, 2017) during the treatment period
9 secondary outcomes
Biodistribution of 177Lu-AKIR001 in major organs and tissues
Time frame: 8 days
Biodistribution of 177Lu-AKIR001 in the whole body
Time frame: 8 days
Pharmacokinetics of 177-Lu and AKIR001 in major organs
Time frame: 29 days
Recommended Phase 2 Dose
Time frame: From first dose to a minimum of 6 weeks post-dose.
Anti-tumor efficacy: radiological response
Time frame: 12 months
Long-term occurrence of adverse events
Time frame: 5 years
Dosimetry of 177Lu-AKIR001
Time frame: 8 days
Anti-tumor efficacy: overall response rate
Time frame: 12 months
Antitumor efficacy: duration of response
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 41198237Mortensen ACL, Mohajershojai T, Gustafsson A, Berglund H, Selvaraju RK, Hofstrom C, Persson H, Ohlin M, Tran TA, Moren AF, Ochniewicz P, Zedenius J, Bernhardt P, Frejd FY, Nestor M. Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials. J Nucl Med. 2026 Feb 2;67(2):269-275. doi: 10.2967/jnumed.125.270782.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [177Lu]Lu-AKIR001 in people with Thyroid Gland Anaplastic Carcinoma and Poorly Differentiated Thyroid Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renske Altena, Associate Professor, MD PhD (+46812375518, renske.altena@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint - rate of dose limiting toxicities (time frame: From first dose to a minimum of 6 weeks post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.