NCT07287748RecruitingPhase 1
A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer
A Phase I Trial of the Alpha Particle-emitting Radiopharmaceutical, Af-001, in Patients With Differentiated Thyroid Cancer
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
This trial consists of 2 parts, i.e., Part Ia and Ib. The Part Ia is to evaluate the safety and tolerability of a single intravenous dose of af-001 in patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) refractory to or intolerant of standard-of-care therapy, who have received total thyroidectomy, and to determine the MTD (Maximum tolerated dose). Part Ib is to evaluate the efficacy and safety of af-001 mutiple doses to patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma), who have received total thyroidectomy and are RAI naïve, randomized into two arms at the determined MTD or the MTD-1 dose level, and to determine the recommended Phase II dose (RP2D)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Alpha Fusion Inc.
- Diseases
- Thyroid cancer
- NCT number
- NCT07287748
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 38
- From 1 Jan 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Patients with active multiple cancers (synchronous multiple cancers and ectopic double cancers with a disease-free period of \<=3 years).
Other
- \<Ia/Ib part\>
- 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.
Who the study is looking for
- \<Ia part\>
- 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 standard-of-care therapy.
- \<Ib part\>
- Patients with radically unresectable, recurrent, metastatic disease who are RAI naive
- Patients with measurable lesions. \<Ia/Ib part\>
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.