Telotristat With Lutathera in Neuroendocrine Tumors

• Status: Recruiting
• Trial end date: 2034-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aman Chauhan
• Collaborators: Lexicon Pharmaceuticals; TerSera Therapeutics LLC

Criteria

Inclusion Criteria:

• Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment

• Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria

• Failure of at least one prior systemic cancer treatment for this diagnosis

• Recovered from AEs of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0

• ECOG performance status ≤2

• normal organ and marrow function

Exclusion Criteria:

• Prior exposure to Lutetium Lu 177 Dotatate

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate.

• Presence of unstable angina or myocardial infarction

• NYHA Class III or IV heart failure

• uncontrolled angina

• history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities

• Pregnant or lactating women

• Women of childbearing potential or male patients of reproductive potential

• Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study