177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland; Krebsforschung Schweiz, Bern, Switzerland; University Hospital Freiburg; University Hospital, Zürich
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination

Criteria

Inclusion Criteria:

• Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy

• 68Ga-DOTATOC PET/CT not older than 12 weeks

• Age > 18 years

• Informed consent

Exclusion Criteria:

• Medication with Vandetanib 3 weeks before the study and during the study

• Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).

• Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).

• Pregnancy and breast feeding

• Known, serious side reaction in the case of a former application of pentagastrin

• Active, second malignancy oder remission after second malignancy < 5 years

• Age over 64 years

• Systolic bood pressure < 112 mmHg at the time of screening

• Simultaneous medication with angiotensin converting enzyme (ACE)-inhibitors, or withdrawal for less than 36 h prior to the medication with Entresto or simultaneous medication with AT-II-receptor blockers

• Known intolerance to Sacubitril or Valsartan

• Known angioedema in anamnesis in the context of a medication with an ACE-inhibitor or an AT-II-receptor blocker