drugset / Trial / NCT06732505
A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens
Phase 1
Recruiting
36 enrolled
Peking University Cancer Hospital & Institute
Sinotau Pharmaceutical Group · collab
NaSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2024-09-29
- Primary completion
- 2025-12-31
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [225Ac]Ac-DOTATATE | Other / unclassified | 0.09 mbq/kg | — |
| Subject | [225Ac]Ac-DOTATATE | Other / unclassified | 0.12 mbq/kg | — |