Clinical trial • Phase I • Oncology
[177Lu]Lu-AKIR001 for Anaplastic thyroid cancer | Thyroid cancer stage IV | Squamous cell carcinoma of head and neck | Squamous cell carcinoma of the cervix | Squamous cell carcinoma of the vulva | Non-small cell lung cancer
Phase I trial of [177Lu]Lu-AKIR001 for Anaplastic thyroid cancer | Thyroid cancer stage IV | Squamous cell carcinoma of head and neck | Squamous cell carc…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Anaplastic thyroid cancer | Thyroid cancer stage IV | Squamous cell carcinoma of head and neck | Squamous cell carcinoma of the cervix | Squamous cell carcinoma of the vulva | Non-small cell lung cancer
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 25-06-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 1 site in Sweden.
- Open Label
- Yes
- Comparator
- None/Not specified
- Biomarker Stratified
- True, biomarker: CD44v6
- Target Sample Size
- 30
Eligibility
Recruits 30 No vulnerable population selected; participants are adults. Consent/assent handling not specified..
- Vulnerable Population
- No vulnerable population selected; participants are adults. Consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 84
- Consent Approach
- Not specified in the record. Participants are adults; specific informed consent/assent procedures, age-specific documents or languages are not provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 20-01-2025
- Processing Time Days
- 147
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Center for Clinical Cancer Studies
- Principal Investigator Name
- Luigi De Petris
- Principal Investigator Email
- Luigi.depetris@regionstockholm.se
- Contact Person Name
- Luigi De Petris
- Contact Person Email
- Luigi.depetris@regionstockholm.se
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Karolinska University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- [177Lu]Lu-AKIR001
- Active Substance
- [177Lu]Lu-AKIR001
- Modality
- Radiopharmaceutical
- First In Human
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)