MedTrace Logo

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

NCT03872778 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-30

No results posted yet for this study

Summary

First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.

Conditions

  • Neoplasms

Interventions

DRUG

[177Lu]-NeoB

\[177Lu\]-NeoB: peptide receptor radionuclide therapy

DRUG

[68Ga]-NeoB

\[68Ga\]-NeoB radioactive diagnostic agent

DRUG

LCZ696

dose strength 49/51 mg, film-coated tablets for oral use

Sponsors & Collaborators

  • Advanced Accelerator Applications

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Study Director · Advanced Accelerator Applications

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2025-01-07
Completion
2025-11-27
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872778 on ClinicalTrials.gov