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

Sinotau Pharmaceutical Group1 site in 1 country74 target enrollmentJune 11, 2024

ConditionsAdvanced Neuroendocrine Neoplasm

InterventionsLutetium[177Lu] Oxodotreotide Injection

DrugsLutetium[177Lu] Oxodotreotide Injection

Overview

Phase: Phase 2
Intervention: Lutetium[177Lu] Oxodotreotide Injection
Conditions: Advanced Neuroendocrine Neoplasm
Sponsor: Sinotau Pharmaceutical Group
Enrollment: 74
Locations: 1
Primary Endpoint: Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 11, 2024

End Date

June 1, 2029

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sinotau Pharmaceutical Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to understand and have willingness to provide a written informed consent document.
•Aged 18 years or older.
•ECOG performance status 0 or
•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.

Exclusion Criteria

•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.

Arms & Interventions

Lutetium[177Lu] Oxodotreotide Injection

Intervention: Lutetium[177Lu] Oxodotreotide Injection

Outcomes

Primary Outcomes

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

Time Frame: Until disease progression or death, up to 5 years

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

Time Frame: Until 6 months after the last dose

Secondary Outcomes

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