A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR). - NeoRay

Overview

No summary available.

Registry

who.int

Start Date

January 23, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Signed informed consent must be obtained prior to participation in the study.
•2\. Adult patients (age \= 18 years old) with advanced solid tumors known to overexpress GRPR.
•3\. \[68Ga]\-NeoB tumor lesion uptake on PET/CT or PET/MRI scan during Selection phase (\= 50% of lesions detected low\-dose CT or MRI acquired together with the \[68Ga]\-NeoB PET have to be \[68Ga]\-NeoB positive)
•4\. At least one measurable lesion per RECIST 1\.1/RANO with a \[68Ga]\-NeoB uptake.
•5\. Patients for whom no standard therapy is available, tolerated or appropriate.
•6\. Presence of at least one tumor lesion confirmed with low\-dose CT or MRIacquired together with the \[68Ga]\-NeoB PET.
•7\. Patient Eastern Cooperative Oncology Group (ECOG) performance status \= 2\.
•8\. Life expectancy more than 6 months.
•9\.Patients must have recovered to \= Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
•Are the trial subjects under 18? no

•1\. Creatinine clearance (calculated using Cockcroft\-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1\.5 x ULN.
•2\. Platelet count of \< 75 x 109/L
•3\. Absolute neutrophil count (ANC) \< 1\.0 x 109/L
•4\. Hemoglobin \< 9 g/dL
•5\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN) if no demonstrable liver metastases or \> 5 x ULN in the presence of liver metastases.
•6\. Total bilirubin \> 1\.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin \= 3 x ULN.
•7\. Serum amylase and/or lipase \> 1\.5 x ULN
•8\. Known or expected hypersensitivity to \[177Lu]\-NeoB, \[68Ga]\-NeoB or any of their excipients.
•9\. Impaired cardiac function or clinically significant cardiac disease
•10\. Patients with diabetes mellitus not stable under the current treatment as judged by the investigator or with fasting plasma glucose \>160 mg/dL (\> 8\.9 mmol/L, CTCAE grade 2\)