Clinical trial NCT06398444: A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Advanced Neuroendocrine Neoplasm
Lead sponsor: Sinotau Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence and severity of adverse events (AE) (Part1)
timeFrame: Until 6 months after the last dose
measure: Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
timeFrame: Until disease progression or death, up to 5 years
Secondary outcomes:
measure: Overall Response Rate (ORR) (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Progression-free survival (PFS) (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Disease Control Rate (DCR) (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Duration of Overall Response (DoR) (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Time to Progression (TTP) (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: PFS rate at 12 months (Part 1)
timeFrame: At 12 months after the first dose
measure: Overall Survival (OS) (Part 1)
timeFrame: Until death of any cause, up to 5 years
measure: Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)
timeFrame: Until disease progression or death, up to 5 years
measure: Progression-free survival (PFS) (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: Disease Control Rate (DCR) (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: Duration of Overall Response (DoR) (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: Time to Progression (TTP) (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: PFS rate at 12 months (Part 2)
timeFrame: At 12 months after the first dose
measure: Overall Survival (OS) (Part 2)
timeFrame: Until death of any cause, up to 5 years
measure: Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: Change From Baseline in the EORTC Quality of Life Questionnaire (Part 2)
timeFrame: Until disease progression or death, up to 5 years
measure: Incidence and severity of AE (Part2)
timeFrame: Until 6 months after the last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: