Early Phase 1 Thyroid Cancer Trial, Recruiting NCT06639191 Sponsor: Karolinska University Hospital Condition: Thyroid Cancer
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Early Phase 1 Thyroid Cancer Trial, Recruiting

NCT06639191
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older who are willing and able to sign a written consent form
  • People who have a solid tumour cancer that has spread or cannot be surgically removed, has tested positive for a protein called CD44v6, and has continued to grow or spread within the last 8 weeks despite standard treatments — with eligible cancer types including certain thyroid cancers (anaplastic, poorly differentiated, or radioiodine-refractory differentiated), head and neck squamous cell cancer (HNSCC), non-small cell lung cancer (NSCLC), vulvar squamous cell cancer, or cervical squamous cell cancer
  • People with thyroid cancer whose tumour carries a specific gene change (BRAFv600E) who have already received BRAF/MEK inhibitor treatment, or whose tumour does not have this gene change and have received at least one appropriate prior treatment (confirm specific treatment history requirements with trial site)
  • People with head and neck squamous cell cancer who have received at least one prior combination chemotherapy regimen together with appropriate additional treatments based on their tumour's test results (confirm specific treatment history with trial site)
  • People with non-small cell lung cancer who have received at least two prior treatment regimens, including an immunotherapy checkpoint inhibitor and a platinum-based chemotherapy
  • People with vulvar squamous cell cancer who have completed both a first-line and a second-line treatment regimen as specified (confirm specific treatment history with trial site)
  • People with cervical squamous cell cancer who have completed at least one line of standard treatment including platinum and paclitaxel-based therapy (confirm specific treatment history with trial site)
  • People who have measurable disease that can be tracked using standard imaging assessment criteria
  • People with a general health and activity level rated as 0 or 1 on a standard performance scale (meaning largely able to carry out normal daily activities with at most mild limitations)
  • People whose doctor estimates they have a life expectancy of at least three months
  • People whose blood counts, kidney function, liver function, and heart function all meet the required levels within eight days before starting treatment (confirm specific values with trial site)
  • Women who could become pregnant must agree to use highly effective contraception during the study and for six months after the last dose, and must have a negative pregnancy test before each treatment infusion
  • Men must agree to use barrier contraception (condoms) or completely avoid heterosexual intercourse during the study and for four months after the last dose

Who may not be able to join:

  • People who have brain metastases (cancer spread to the brain) that are causing symptoms, have not been previously treated, or currently require steroid medications to manage them
  • People who have been diagnosed with another cancer within the past five years, unless it was a completely treated skin cancer (basal or squamous cell) or cervical carcinoma in situ
  • People who have received chemotherapy, targeted therapy, or radiotherapy within the four weeks before enrolling in the study
  • People who still have significant side effects (rated above grade 1) from previous cancer treatments that have not resolved
  • People who are pregnant or breastfeeding
  • People with uncontrolled high blood pressure, or uncontrolled heart, liver, or kidney disease, or other serious medical or psychiatric conditions
  • People with severe skin diseases that require systemic anti-inflammatory treatment, such as plaque psoriasis, Stevens-Johnson syndrome, or dermatomyositis
  • People with a known history of HIV infection, active hepatitis B, active hepatitis C, or active tuberculosis

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: +46812375518

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Karolinska University Hospital
Registry
ClinicalTrials.gov
Start date
28 January 2026
Est. completion
1 November 2027

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Primary Endpoint - rate of dose limiting toxicities

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov