NCT06663072

Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.

Detailed description

Patients with metastatic pancreatic neuroendocrine tumors (pNETs) suffer from a diminished lifespan. Newer therapies such as Peptide Receptor Radionuclide Therapy (PRRT), using 177Lu-DOTATATE, have aimed to improve survival in metastatic NETs, but result in palliation rather than cure. Combining radioligand therapies (RLT) with radiosensitizers has not been widely explored in the clinical setting, but encouraging pre-clinical data makes this a sensible approach. In this study the investigators will assess the safety combining 177Lu-DOTATATE in combination with Fulvestrant in patients with pancreatic tumors. The investigators will also seek to learn on how well people respond to the combination by measuring changes in tumor size.

Conditions

• Metastatic Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Fulvestrant	Safety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.
DRUG	177Lu-DOTATATE	Safety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles.

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-10-29
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study