Study on [177Lu]-NeoB for Patients with Advanced Solid Tumors Showing [68Ga]-NeoB Uptake

Sponsor: Advanced Accelerator Applications

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03872778

Provider View

This clinical trial is testing a new treatment called [177Lu]-NeoB for patients with advanced solid tumors that show uptake of [68Ga]-NeoB. The study aims to understand the safety, how the drug moves in the body, and its effects on tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effects of a new treatment, [177Lu]-NeoB, in patients with advanced solid tumors that have a specific marker called Gastrin-Releasing Peptide Receptor (GRPR) and show uptake of [68Ga]-NeoB. The study will look at how the drug is tolerated, how it spreads in the body, and its potential to reduce tumors.

Description

This study is divided into two parts: Phase I and Phase IIa.

Phase I (Dose Escalation):

  • This part of the study will include adult patients (18 years and older) with advanced or metastatic solid tumors such as breast cancer, lung cancer, prostate cancer, gastrointestinal stromal tumor (GIST), and glioblastoma (GBM) who have no other standard treatment options. Patients must show [68Ga]-NeoB uptake in their tumors.
  • The goal is to find the safest dose of [177Lu]-NeoB by gradually increasing the dose given to patients.
  • Efforts will be made to include both male and female patients at each dose level.

Phase IIa (Expansion):

  • This part will include adult patients with specific types of advanced or metastatic solid tumors:
    • Cohort A: Breast cancer that is hormone receptor-positive and HER-2 negative.
    • Cohort B: Prostate cancer.
    • Cohort C: GIST.
    • Cohort D: Any advanced solid tumor known to overexpress GRPR, including recurrent GBM, with moderate kidney function impairment.
    • Cohort E (US and UK only): Patients with advanced tumors eligible for Cohorts A, B, or C, receiving [177Lu]-NeoB with another drug, LCZ696.
  • Note: Enrollment in Cohort D is no longer allowed under the latest protocol version.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Adults (18 years or older) with advanced or metastatic solid tumors:
    • Phase I: Breast cancer, lung cancer, prostate cancer, GIST, GBM.
    • Phase IIa:
      • Cohort A: Breast cancer, hormone receptor-positive, HER-2 negative.
      • Cohort B: Prostate cancer.
      • Cohort C: GIST.
      • Cohort D: Advanced solid tumors with GRPR overexpression and moderate kidney impairment.
      • Cohort E: Breast cancer, prostate cancer, or GIST.
  • Must have at least one measurable tumor that shows [68Ga]-NeoB uptake.
  • No standard therapy available, tolerated, or appropriate.
  • ECOG performance status:
    • Phase I: 0 to 2.
    • Phase IIa: 0 to 1.

Exclusion Criteria

  • Unresolved significant side effects from previous cancer treatments.
  • Poor kidney function (varies by cohort).
  • Low blood cell counts or liver function outside specified limits.
  • Known allergies to [177Lu]-NeoB or [68Ga]-NeoB.
  • Heart problems or uncontrolled diabetes.
  • Recent use of certain cancer treatments or investigational drugs.
  • Other active cancers or serious health conditions.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using effective contraception.
  • Men must use condoms during treatment and for 4 months after.
  • Use of other investigational drugs within 30 days before the study.

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