Phase II Study of 161Tb‑Labeled Gastrin Analogue for Precision Therapy in Patients with Advanced Medullary Thyroid Cancer

The trial enrolled individuals diagnosed with Thyroid cancer. Both female and male patients were eligible, and enrollment covered the age categories indicated by codes 3 and 4, representing adult and older adult groups, although exact ages were not disclosed. The sponsor did not provide the total number of participants, nor details on the selection method, lifestyle considerations, or specific inclusion and exclusion criteria.

The study is a Phase 1 clinical trial evaluating a medullary thyroid cancer therapeutic agent labeled with 161Tb. Recruitment is planned to begin in August 2026 and the trial is expected to conclude by September 2031. After obtaining informed consent, participants undergo a screening visit to confirm eligibility, including medical history, laboratory tests, and imaging assessments. Eligible subjects then receive the investigational product and attend scheduled follow‑up visits at predetermined intervals for safety monitoring, pharmacokinetic sampling, and efficacy evaluations. The trial duration for each participant extends from the first dosing visit through the final end‑of‑study visit, encompassing all required assessments over several months. Early termination may occur if a participant experiences a serious adverse event related to the study drug, withdraws consent, or fails to adhere to the protocol requirements. All visits are documented, and data collection follows a predefined schedule to ensure consistent evaluation of safety and preliminary efficacy outcomes throughout the study period.

Assessments of efficacy will be conducted in accordance with the study protocol for participants with thyroid cancer.