Differentiated thyroid cancer (papillary carcinoma, follicular carcinoma).
Conditions
Interventions
af-001 will be administered intravenously as a single or multiple dose.
Sponsors
Ishida Nobuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Safety evaluations (Adverse events, Adverse drug reaction, Abnormal laboratory test result). (2) Dose-limiting toxicities (DLTs). (1) Efficacy evaluations: Tumor shrinkage assessment. (2) Safety evaluations (Adverse events, Adverse drug reaction, Abnormal laboratory test result). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Secondary endpoints related to safety. (2) Evaluation of pharmacokinetic parameters. (3) Evaluation of biodistribution imaging and absorbed dose using a gamma camera. (4) Preliminary efficacy evaluations. 1) Tumor shrinkage assessment. 2) Tumor markers (thyroglobulin in blood) over time. (1) Duration of response. (2) Tumor markers (thyroglobulin in blood). (3) Changes in [131I] NaI uptake. (4) Progression-free survival at Month 12. | — |
Contacts
Public ContactHiroaki Kitajima
Alpha Fusion Inc.
Outcome results
None listed