A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms

August 28, 2025 updated by: Sinotau Pharmaceutical Group

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lutetium[177Lu] Oxodotreotide Injection
Drug: Lutetium[177Lu] Oxodotreotide Injection
Participants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events (AE) (Part1)
Time Frame: Until 6 months after the last dose
Until 6 months after the last dose
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR) (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 1)
Time Frame: At 12 months after the first dose
At 12 months after the first dose
Overall Survival (OS) (Part 1)
Time Frame: Until death of any cause, up to 5 years
Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 2)
Time Frame: At 12 months after the first dose
At 12 months after the first dose
Overall Survival (OS) (Part 2)
Time Frame: Until death of any cause, up to 5 years
Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 2)
Time Frame: Until disease progression or death, up to 5 years
Until disease progression or death, up to 5 years
Incidence and severity of AE (Part2)
Time Frame: Until 6 months after the last dose
Until 6 months after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinotau Pharmaceutical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XT-XTR008-2-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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