TheranosticTrials.org

Clinical Trial · NCT06732505

A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens

Overview

This is a phase I study to assess the safety and efficacy of \[225Ac\]Ac-DOTATATE in patients with inoperable, locally advanced or metastatic, progressive, Well-Differentiatedwell differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine neoplasms with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT).

Sponsor

Peking University Cancer Hospital & Institute

Phase

Phase 1

Contacts

Zhi Yang (CONTACT)

pekyz@163.com

010-88196196

ClinicalTrials.gov

NCT06732505

Drug / Compound

DOTATATE

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

Eligibility

Inclusion

  • Sufficient bone marrow capacity and organ function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula). Hemoglobin≥90g/L, neutrophil count ≥1.5×10\^9/L, platelets≥100×10\^9/L. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g/L. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT/AST≤5×ULN with liver metastases. Partially activated prothrombin time (APTT) ≤1.5 x ULN.
  • SSTR-PET positive.
  • Unresectable locally advanced or metastatic GEP-NET which confirmed by imaging examination.
  • G1 or G2 NET patients: previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression;G3 NET orNEC patients: previously received at least 1 line therapy with disease progression.
  • Histopathologically confirmed G1 or G2 or G3 GEP-NET or GEP-NEC；
  • ECOG score of 0 or 1.
  • Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.
  • Life expectancy of at least 12 weeks.
  • Presence of at least 1 measurable site of disease (based on RECIST 1.1).

Exclusion

  • Uncontrolled congestive heart failure.
  • 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.
  • Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency.
  • Received the following treatments within 4 weeks prior to initiation of study treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
  • uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
  • Unsuitable for the study for any reason, in the opinion of the investigator.
  • Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
  • Pregnant or lactating females.
  • Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or \[225Ac\]Ac-DOTATATE Injection and their excipients.
  • Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study.
  • Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.
  • Rapid progression with previous PRRT therapy.
  • Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
  • Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of initiation of study treatment, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of initiation of study treatment.
  • Received external beam radiation therapy for bone metastases within 2 weeks prior to initiation of study treatment.
  • Any clinically significant active infection.
  • Participated in other drug clinical trials within 4 weeks prior to initiation of study treatment and received treatment with the corresponding trial drug.
  • Known other malignancies (except for those without recurrence within 5 years after adequate treatment).