Actively Recruiting
A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer
Led by Alpha Fusion Inc. · Updated on 2025-12-31
38
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) after total thyroidectomy
- Patients with radically unresectable, recurrent, metastatic disease judged refractory to or intolerant of standard therapy (Part Ia)
- Patients with radically unresectable, recurrent, metastatic disease who are radioactive iodine (RAI) naive (Part Ib)
- Patients with measurable lesions (Part Ib)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and stable general condition
- Expected survival of at least 6 months based on clinical evaluation
You will not qualify if you...
- Patients who need to preserve fertility
- Females who are pregnant, may be pregnant, breastfeeding, or patients/partners who cannot agree to use contraception
- Patients with active multiple cancers within 3 years
- Patients with uncontrolled active infections
- Patients positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital East
Kashiwa, Japan
Actively Recruiting
Research Team
A
Alpha Fusion Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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