A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06398444
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sinotau Pharmaceutical Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Neuroendocrine Neoplasm

Additional Details

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.

Arms & Interventions

Arms

Experimental: Lutetium[177Lu] Oxodotreotide Injection

Interventions

Drug: - Lutetium[177Lu] Oxodotreotide Injection

Participants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai,

Site Contact

Jie Chen, MD

[email protected]

+86-021-68070288

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