The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

NCT Number	NCT07459283
Lead Sponsor	FindCure Biosciences (ZhongShan) Co., Ltd. Collaborators: Affiliated Hospital of Jiangnan University
Conditions	Maligant Solid Tumor, Head & Neck Cancer, Thyroid Cancer, Lung Cancer - Non Small Cell Squamous, Breast Cancer, Sarcoma
Enrollment	10 participants
Start Date	2026-04
Primary Completion	2026-12 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-10