TheranosticTrials.org

Clinical Trial · NCT07057622

A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs

Overview

The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS

Sponsor

HTA Co., Ltd.

Phase

Phase 3

Contacts

Li Huo, M.D. (CONTACT)

huoli@pumch.cn

(86)10-69158354

ClinicalTrials.gov

NCT07057622

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;
  • BaselineECOG score 0 or 1;
  • Adeguate organ and bone marrow function as defined below: a) bone marrow:Neutrophil count (ANC)≥1.5×109/L, platelet count ≥75×109/L,hemoglobin ≥80g/L,no blood transfusion or growth factor treatment within 14 days before randomization.(colony stimulating factor (CSF), colony stimulating factor (CSF),Erythropoietin(EPO),etc.); b) Liver function:aspartate aminotransferase(AST)and alanine aminotransferase(ALT)≤2.5 ULN; total bilirubin( TBIL ) ≤1.5 × ULN; c ) Renal function : serum creatinine ≤150μmol/ L or 1.7mg / dL, or creatinine clearance rate (CLcr)≥50mL/min calculated by Cockroft Gault method; d) Baseline left ventricular ejection fraction (LVEF)≥50 % measured by multi-gate circuit controlled acquisition(MUGA) or echocardiography(ECHO); e ) Coagulation function: international normalized ratio(INR)≤1.5 ×ULN,activated partial thromboplastin time(APTT ) ≤1.5 × ULN ; f) Serum albumin \> 3.0g/ dL.
  • Subjects with childbearing potential voluntarily use effective contraceptive methods,such as condoms, oral or injectable contraceptives, intrauterine devices, etc, during treatment and within 4 months (men) or 7months(women)after the last use of the investigational drug.
  • Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium \[68Ga\] dobutamine injection as somatostatin receptor positive(IRC confirmed);
  • There is at least one measurable lesion at baseline;

Exclusion

  • Received the following treatments within 12 weeks before randomization,including but not limited to surgery (except biopsy),radical radiotherapy,hepatic artery interventional embolization,cryoablation or radiofrequency ablation of liver metastases;
  • Have received systemic anti-tumor treatments such as targeted therapy, immunotherapy,anti-tumor Chinese medicine treatment, chemotherapy,etc.within 4 weeks before randomization;
  • The toxicity of previous anti-tumor treatment has not recovered to s grade 1 level (except for hair loss and neurotoxicity);
  • Received Octreotide LAR treatment with a dose intensity \>30 mg/3-4 weeks (increased dose or frequency) within 12 weeks before randomization;
  • Pregnant or lactating women;
  • Received palliative radiotherapy for bone metastases within 2 weeks before randomization;
  • Received peptide receptor radionuclide therapy (PRRT) before randomization;
  • Participated in other drug clinical trials and received corresponding experimental drugs within 4 weeks before randomization, except for the PET/CT study of the diagnostic drug68Ga-DOTATATE injection initiated by the sponsor of this trial;
  • Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));
  • Severe cardiac insufficiency,including congestive heart failure 2 grade 2 (New York Heart Association classification), myocardial infarction, stroke or transient ischemic attack (TIA) history within 6 months before enrollment; 14.History of ventricular tachycardia or torsade de pointes.Any clinically important abnormality in resting ECG rhythm, conduction,or morphology, such as QTcF \>450 msec in men or QTcF\>470 msec in women, the presence of complete left bundle branch block or third-degree atrioventricular block;15\. Pulmonary embolism or deep vein thrombosis occurred within 3months before randomization; 16.Uncontrolled hypertension(e.g.systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg)and uncontrolled diabetes ( baseline fasting blood glucose \>8.9 mmol/ L or glycosylated hemoglobin(HbA1C)\>6.5%); 17.There were uncontrolled active bacterial, viral,fungal,rickettsial or parasitic infections requiring intravenous anti-infective therapy within the first 2 weeks of randomization; 18.There were concurrent malignant tumors within the first 5 years of enrollment (except for fully treated cervical carcinoma in situ,localized skin squamous cell carcinoma,basal cell carcinoma, prostate cancer without anti-tumor treatment,thyroid cancer,breast ductal carcinoma in situ, and urothelial carcinoma below T1); 19. Known allergies to 68Ga-DOTATATE injection or 177Lu-DOTATATE injection or Octreotide LAR components and theirexcipients; 20. Any other disease or mental state that is not under control and may affect the completion of the study (including poor compliance) or is not suitable for the use of experimental drugs; 21.According to the patient \'s disease characteristics,the researchers believe that other treatment options (such as chemotherapy,targeted therapy) are more suitable for patients than the treatment provided in the study,that is,the experimental drugs are not the best therapeutic drugs in clinical practice.
  • Known brain metastasis (except those who have received treatment and been stable for at least 24 weeks before randomization);
  • Human immunodeficiency virus (HIV) antibody positive;
  • Subjects who are receiving short-acting octreotide treatment cannot stop short-acting octreotide within 24 hours before and 24 hours after administration of 177Lu-DOTATATE or subjects who are receiving Octreotide LAR treatment cannot stop Octreotide LAR within 4 weeks before administration of 177Lu-DOTATATE;