utetium (177Lu) Edotreotide versus Best Standard of Care in Well-differentiated Aggressive Grade 2 and Grade 3 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Phase 1

Recruiting

Conditions: Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET)
MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2
MedDRA version: 20.0Level: PTClassification code: 10077559Term: Gastroenteropancreatic neuroendocrine tumour disease Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-510812-64-00

Lead Sponsor: ITM Solucin GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 202

Inclusion Criteria

1. Patients aged =18 years., 2. Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI)., 3. Somatostatin receptor-positive (SSTR+) disease.

Exclusion Criteria

1. Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin)., 2. Prior (Peptide Receptor Radionuclide Therapy) PRRT., 3. Any major surgery within 4 weeks prior to randomization in the trial., 4. Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization., 5. Other known malignancies., 6. Serious non-malignant disease., 7. Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments., 8. Pregnant or breastfeeding women., 9. Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of PRRT with lutetium (177Lu) edotreotide in the treatment of aggressive Grade 2 (G2; Ki67 between 15 and 20, both inclusive) and Grade 3 (G3; Ki-67 above 20 up to 55, inclusive) SSTR+ GEP-NETs compared to best standard of care (Investigator's choice [from the protocol comparator list]).;Secondary Objective: 1. To further demonstrate the efficacy of PRRT with lutetium (177Lu) edotreotide., 2. To assess the impact of PRRT with lutetium (177Lu) edotreotide on trial patient's health-related quality of life (HRQL) and neuroendocrine functional tumor symptoms during and after therapy in comparison to best standard of care., 3. To assess the safety and tolerability of PRRT with lutetium (177Lu) edotreotide in trial patients compared to control treatment options.;Primary end point(s): Progression-free survival (PFS)

Secondary Outcome Measures