A Phase I Trial of Af-001 in Patients With Differentiated Thyroid Cancer

Recruiting now · Phase 1

Conditions studied: DTC - Differentiated Thyroid Cancer

In brief

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)

Key facts

Study ID

NCT07287748

Run by

Alpha Fusion Inc.

People needed

38

Starts

2026-01-01

Expected to finish

2028-07-31

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• <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.

You may not qualify if…

• <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.
• 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.

Where it is running

• National Cancer Center Hospital East — Kashiwa, Japan (enrolling)

Full record on ClinicalTrials.gov

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