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New treatment option for Thyroid Gland Anaplastic Carcinoma
Official title [177Lu]Lu-AKIR001 First-in-human Study
ClinicalTrials.gov ID: NCT06639191
What this study is testing
What is [177Lu]Lu-AKIR001?
[177Lu]Lu-AKIR001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thyroid gland anaplastic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):
- For BRAFv600E mutated tumours: BRAF/MEK inhibitors.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.