DTC - Differentiated Thyroid Cancer study: [211At]NaAt
Official title A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT07287748
What this study is testing
What is [211At]NaAt?
An investigational intravenous drug being studied for differentiated thyroid cancer.
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 study first checks how safe a single IV dose of Af-001 is and finds the highest dose people can tolerate. Then it looks at how well repeated doses work and what dose should be used in future studies.
- Who it's for
- Adults who have had their thyroid removed, have advanced papillary or follicular thyroid cancer that has come back or spread, and whose usual treatments no longer work or cause problems.
- What's involved
- Participants receive the drug through an IV and may be given it once or several times. They will have medical visits and tests to monitor safety and any changes in their cancer.
- Time commitment
- The study lasts several months, with multiple clinic visits for drug administration and safety monitoring. The exact length depends on the part of the study the participant is in.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) after total thyroidectomy.
- Patients with radically unresectable, recurrent, metastatic disease who are judged by the principal investigator or sub-investigator (hereinafter...
- Patients with radically unresectable, recurrent, metastatic disease who are RAI naive
- Patients with measurable lesions. \
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 and stable general condition.
You likely can't join if
- Patients who need to preserve fertility.
- Females who are pregnant or may be pregnant, breastfeeding patients, or patients or their partners who cannot agree to appropriate contraception.
- Patients with active multiple cancers (synchronous multiple cancers and ectopic double cancers with a disease-free period of \<=3 years).
- Patients with uncontrolled active infections.
- Patients who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV)...
See the full eligibility criteria
- Patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) after total thyroidectomy.
- Patients with radically unresectable, recurrent, metastatic disease who are judged by the principal investigator or sub-investigator (hereinafter, "principal/sub-investigators") to be refractory to or intolerant of...
- Patients with radically unresectable, recurrent, metastatic disease who are RAI naive
- Patients with measurable lesions. \
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 and stable general condition.
- Patients expected to survive for at least 6 additional months based on clinical symptoms and physical examination findings.
- Patients who need to preserve fertility.
- Females who are pregnant or may be pregnant, breastfeeding patients, or patients or their partners who cannot agree to appropriate contraception.
- Patients with active multiple cancers (synchronous multiple cancers and ectopic double cancers with a disease-free period of \<=3 years).
- Patients with uncontrolled active infections.
- Patients who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies.
The study team makes the final eligibility decision.
Where it is enrolling
- Kashiwa, Japan
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, but 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?
This study is enrolling now at Kashiwa, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.