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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorSinotau Pharmaceutical Group

About this trial

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) and Neuroendocrine Carcinoma(NEC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).

Age ≥12 years; subjects aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.

⁶⁸Ga-Dotatate PET/CT images obtained within 24 weeks before the first drug administration are acceptable if investigators verify they can reflect the somatostatin receptor status at enrollment;

Somatostatin receptor positivity is defined as lesion uptake higher than normal liver uptake;

Disqualifiers

Serum creatinine > 150 μmol/L (1.7 mg/dL) or creatinine clearance rate < 50 mL/min (calculated by Cockcroft-Gault formula).

Hemoglobin < 100 g/L, white blood cell count < 2.0×10⁹/L, or platelet count < 100×10⁹/L.

Total serum bilirubin > 3 times the upper limit of normal (ULN).

Serum albumin < 30 g/L.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lutetium[177Lu] Oxodotreotide Injection

    Drug

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

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Lutetium[177Lu] Oxodotreotide InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Until 6 months after the last dose
2

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

Time frame
Until disease progression or death, up to 5 years

Secondary outcomes

1

Overall Response Rate (ORR) (Part 1)

Time frame
Until disease progression or death, up to 5 years
2

Progression-free survival (PFS) (Part 1)

Time frame
Until disease progression or death, up to 5 years
3

Disease Control Rate (DCR) (Part 1)

Time frame
Until disease progression or death, up to 5 years
4

Duration of Overall Response (DoR) (Part 1)

Time frame
Until disease progression or death, up to 5 years

Other outcomes

Sponsors and contacts

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