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

NCT ID: NCT06398444

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2029-06-01

Brief 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.

Conditions

Advanced Neuroendocrine Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lutetium[177Lu] Oxodotreotide Injection

Group Type: EXPERIMENTAL

Lutetium[177Lu] Oxodotreotide Injection

Intervention Type: DRUG

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

Interventions

Lutetium[177Lu] Oxodotreotide Injection

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinotau Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XT-XTR008-2-02

Identifier Type: -

Identifier Source: org_study_id