[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake (NeoRay)

[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake (NeoRay)

Gastrointestinal Stromal Tumor

Recruiting

1/2

Start Date 07/24/2019

Age of Trial (yrs) 5.3

Gleevec-resistant

Theranostic

Radio labeled tracer for GRPR expressing malignancies

Specifically GIST plus other cancers

CAAA603A12101 2018-004727-37 ( EudraCT Number ) 2023-507170-41-00

Advanced Accelerator Applications

Novartis Pharmaceuticals 1-888-669-6682 +41613241111 novartis.email@novartis.com

Intravenous

Brief Summary
The purpose of this first-in-human (FIH) study of [177Lu]-NeoB is to characterize the safety, tolerability, pharmacokinetics (PK) as well as the distribution and radiation dosimetry, and anti-tumor activity of [177Lu]-NeoB in patients with advanced solid tumors known to overexpress Gastrin-Releasing Peptide Receptor (GRPR) and with [68Ga]-NeoB lesion uptake.
Detailed Description

This is a Phase I/IIa study which consists of a dose escalation (Phase I) and an expansion part (Phase IIa).

Dose escalation (Phase I):

Phase I study will be conducted in adult patients (age >= 18 years old) with any of the following selected advanced or metastatic solid tumors: breast cancer, lung cancer, prostate cancer, gastro intestinal stromal tumor (GIST), and glioblastoma (GBM) for whom no standard therapy is available, tolerated or appropriate, and with [68Ga]-NeoB lesion uptake as defined in the inclusion criteria.

In Phase I, every effort must be made to include at least one patient of each gender (male/female) in each Dose level to obtain dosimetry data for each gender at all Dose levels tested. However, if it is not feasible, at least 3 patients of each gender must be included in the study before reaching the [177Lu]-NeoB Dose level of 100% estimated cumulative dose (ECD) (Dose level 4) or the maximum tolerated dose (MTD) / recommended phase two dose (RP2D), whichever is lower.

Expansion part (Phase IIa):

The Phase IIa study will be conducted in adult patients (age >= 18 years old) with:

For Cohorts A, B, C respectively: Any of the following selected advanced or metastatic solid tumors: breast cancer (human receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2) negative including HER 2 low), prostate cancer, and GIST all showing [68Ga]-NeoB lesion uptake.
For Cohort D: Patients affected by any advanced/metastatic solid tumor type known to overexpress GRPR, including recurrent GBM, and with moderate impaired renal function defined as creatinine clearance (calculated using the Cockcroft-Gault formula, or measured) ≥ 30mL/min and < 60mL/min.

For Cohort E (US and UK only): Patients eligible for enrollment in any of the three advanced/metastatic tumor types (as defined for Cohorts A, B, C) who will receive the first cycle of [177Lu]-NeoB upon co-administration with LCZ696
Enrollment in cohort D will no longer be allowed with implementation of protocol version 07.