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

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 29, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Neuroendocrine Neoplasm
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."

Trial Locations (1)

100000

RECRUITING

Peking University Cancer Hospital & Institute, Beijing

All Listed Sponsors
collaborator

Sinotau Pharmaceutical Group

INDUSTRY

lead

Peking University Cancer Hospital & Institute

OTHER