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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
[211At]NaAt
DrugMTD or MTD-1 level to be tested
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: [211At]NaAtExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
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 \[\*: Grades as defined in CTCAE v.5.0 (Japanese translation) JCOG version\]
Time frame
4 weeks2
Ph1b: Assessment of tumor reduction effect on MRI or CT scan images
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.
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov