Status:
COMPLETED
Evaluation of 177Lu-TATE-EB-01（LNC1010）in SSTR2-positive Tumors
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
SSTR2-positive Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
177Lu-LNC1010(177Lu-EB-TATE-01) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive tumors. In this study, we designed and developed a...
Detailed Description
Somatostatin receptor(SSTR), especially SSTR subtype 2 (SSTR2),has been a popular target for molecular imaging and radionuclide therapy in recent years. SSTR antagonists, such as LNC1010, have emerged...
Eligibility Criteria
Inclusion
- Aged 18 years or older;
- Histologically proven or cytologically confirmed SSTR positive cancers;
- Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1;
- Overexpression of somatostatin receptors of the target lesions at 68Ga-DOTA-TATE positron emission tomography (PET)/computed tomography (CT) with standard uptake value(SUV) of lesions greater than normal liver in at least 1 lesion;
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion
- Women who are pregnant or breastfeeding;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-EB-TATE as assessed from medical records;
- Previous radioligand treatment with 177Lu-DOTA-TATE;
- Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever is longer, before the first administration of study drug;
- Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug;
- Life expectancy \< 3 months as assessed by the treating physician;
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05410743
Start Date
June 1 2022
End Date
March 24 2025
Last Update
March 25 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, China, 361000