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

ConditionDTC - Differentiated Thyroid Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlpha Fusion Inc.

About this trial

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)

Eligibility criteria

Qualifiers

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.

Patients with radically unresectable, recurrent, metastatic disease who are RAI naive

Patients with measurable lesions. <Ia/Ib part>

Disqualifiers

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.

Trial design

Treatments tested in this trial

[211At]NaAt

Treatment groups

38 Participants

are divided into 1 treatment group

Sponsors and collaborators

Alpha Fusion Inc.

Lead sponsor

Source ClinicalTrials.gov