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

Condition(s) studied

Investigational drug(s) / intervention(s)

[211At]NaAt: MTD or MTD-1 level to be tested

Study summary

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

Primary outcome measure(s)

• Ph1a: DLT (Dose-limiting toxicity ) based on Japanese translation of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Japan Clinical Oncology Group (JCOG) version — 4 weeks
  DLT evaluation criteria: 1. Grade ≥4\* hematologic toxicity that persists for at least 7 days 2. Febrile neutropenia regardless of duration 3. Grade ≥3\* thrombocytopenia associated with a bleeding tendency or that requires platelet transfusions 4. Anemia that requires red blood cell transfusions 5. Neutropenia associated with infection 6. Grade ≥3\* non-hematologic toxicity that persists for at least 7 days and does not improve with symptomatic treatment, with the following exceptions: * Toxicities that can be controlled to Grade ≤2\* with maximum supportive herapy * Those due to the progression of the primary tumor \[\*: Grades as defined in CTCAE v.5.0 (Japanese translation) JCOG version\]
• Ph1b: Assessment of tumor reduction effect on MRI or CT scan images — 24 weeks
  Using the "Revised version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 (Japanese translation of JCOG version 1.0)" as a reference.

Trial sites (1)