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Trial Title:
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
NCT ID:
NCT06398444
Condition:
Advanced Neuroendocrine Neoplasm
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium[177Lu] Oxodotreotide Injection
Description:
Participants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8
weeks.
Arm group label:
Lutetium[177Lu] Oxodotreotide Injection
Summary:
This is a multicenter, single-arm, two-part study designed to evaluate the safety and
efficacy of Lutetium [177Lu] Oxyoctreotide Injection in patients with inoperable, locally
advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive
neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic
neuroendocrine tumors (GEP-NET).
Detailed description:
This study consists of two parts, the exploratory study (Part 1) and the pivotal study
(Part 2).
In both parts, participants who signs Informed consent form (ICF) and is eligible for the
study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium [177Lu]
Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks
from the time of the first dose according to RECIST 1.1 until disease progression.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to understand and have willingness to provide a written informed consent
document.
2. Aged 18 years or older.
3. ECOG performance status 0 or 1.
4. Histopathologically confirmed, unresectable locally advanced or metastatic NEN .
5. Disease progression before first dose.
6. Subjects of childbearing potential should voluntarily use an effective method of
contraception during treatment and within 4 months (male) or 7 months (female) of
the last dose.
Exclusion Criteria:
1. Known brain metastases, unless these metastases have been treated and stabilized for
at least 24 weeks prior to enrollment in the study.
2. Uncontrolled congestive heart failure, including baseline left ventricular ejection
fraction (LVEF) <50%.
3. Uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
4. Any clinically significant active infection.
5. Pregnant or lactating females.
6. Received systemic antitumor therapy such as targeted therapy, immunotherapy,
antitumor herbal therapy or chemotherapy within 4 weeks prior to enrollment.
7. Known other malignancies (except for those without recurrence within 5 years after
adequate treatment).
8. Any other disease, mental status or surgical condition that is uncontrolled, may
interfere with study completion (including poor compliance) or is inappropriate for
the use of the investigational drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Jie Chen, MD
Phone:
+86-021-68070288
Email:
Chen0jie@hotmail.com
Start date:
June 1, 2024
Completion date:
June 1, 2029
Lead sponsor:
Agency:
Sinotau Pharmaceutical Group
Agency class:
Industry
Source:
Sinotau Pharmaceutical Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398444
