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RECRUITING
NCT06732505
PHASE1

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

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With Inoperable, Locally Advanced or Metastatic, Progressive, Well-Differentiated,SSTR+ GEP-Nens

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-09-29

Completion Date

2026-03-31

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

DRUG

[225Ac]Ac-DOTATATE

The dose escalation phase will be divided into two cohorts: patients who had previously received 177Lu-PRRT will be enrolled in cohort 1, and patients who had not received 177Lu-PRRT will be enrolled in cohort 2. Dose escalation was performed independently in the two cohorts. DL1 will be administered as a dose of 90kBq/kg per cycle, and DL2 will be administered as a single dose of 120kBq/kg per cycle.Every patient will receive one \[225Ac\]Ac-DOTATATE infusion every 8 weeks for up to 4 cycles. The dose expansion phase will be divided into 3 cohorts based on Ki-67 index.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China