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

NCT06398444 | Active Not Recruiting Phase 2

• 1 other identifier: XT-XTR008-2-02
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Neuroendocrine Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AE) (Part1)

  Until 6 months after the last dose

• Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)

  Until disease progression or death, up to 5 years

Secondary Outcomes (18)

• Overall Response Rate (ORR) (Part 1)

  Until disease progression or death, up to 5 years

• Progression-free survival (PFS) (Part 1)

  Until disease progression or death, up to 5 years

• Disease Control Rate (DCR) (Part 1)

  Until disease progression or death, up to 5 years

• Duration of Overall Response (DoR) (Part 1)

  Until disease progression or death, up to 5 years

• Time to Progression (TTP) (Part 1)

  Until disease progression or death, up to 5 years

Study Arms (1)

Lutetium[177Lu] Oxodotreotide Injection

EXPERIMENTAL

Drug: Lutetium[177Lu] Oxodotreotide Injection

Interventions

Lutetium[177Lu] Oxodotreotide Injection DRUG

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

Lutetium[177Lu] Oxodotreotide Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and have willingness to provide a written informed consent document.
• Aged 18 years or older.
• ECOG performance status 0 or 1.
• Histopathologically confirmed, unresectable locally advanced or metastatic NEN .
• Disease progression before first dose.
• 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.

You may not qualify if:

• Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks prior to enrollment in the study.
• Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \<50%.
• Uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
• Any clinically significant active infection.
• Pregnant or lactating females.
• Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy or chemotherapy within 4 weeks prior to enrollment.
• Known other malignancies (except for those without recurrence within 5 years after adequate treatment).
• 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.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

lutetium Lu 177 dotatate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)