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

Advanced Neuroendocrine Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398444
• Other study ID #: XT-XTR008-2-02
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: May 2024
• Source: Sinotau Pharmaceutical Group
• Contact: Shan Zhang
• Phone: +86-010-52805710
• Email: zhangshan[@]sinotau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Neuroendocrine Neoplasm
• Neoplasms
• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sinotau Pharmaceutical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AE) (Part1)		Until 6 months after the last dose
Primary	Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)		Until disease progression or death, up to 5 years
Secondary	Overall Response Rate (ORR) (Part 1)		Until disease progression or death, up to 5 years
Secondary	Progression-free survival (PFS) (Part 1)		Until disease progression or death, up to 5 years
Secondary	Disease Control Rate (DCR) (Part 1)		Until disease progression or death, up to 5 years
Secondary	Duration of Overall Response (DoR) (Part 1)		Until disease progression or death, up to 5 years
Secondary	Time to Progression (TTP) (Part 1)		Until disease progression or death, up to 5 years
Secondary	PFS rate at 12 months (Part 1)		At 12 months after the first dose
Secondary	Overall Survival (OS) (Part 1)		Until death of any cause, up to 5 years
Secondary	Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)		Until disease progression or death, up to 5 years
Secondary	Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)		Until disease progression or death, up to 5 years
Secondary	Progression-free survival (PFS) (Part 2)		Until disease progression or death, up to 5 years
Secondary	Disease Control Rate (DCR) (Part 2)		Until disease progression or death, up to 5 years
Secondary	Duration of Overall Response (DoR) (Part 2)		Until disease progression or death, up to 5 years
Secondary	Time to Progression (TTP) (Part 2)		Until disease progression or death, up to 5 years
Secondary	PFS rate at 12 months (Part 2)		At 12 months after the first dose
Secondary	Overall Survival (OS) (Part 2)		Until death of any cause, up to 5 years
Secondary	Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)		Until disease progression or death, up to 5 years
Secondary	Change From Baseline in the EORTC Quality of Life Questionnaire (Part 2)		Until disease progression or death, up to 5 years
Secondary	Incidence and severity of AE (Part2)		Until 6 months after the last dose