CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
[177Lu]-NeoB +2 moredrug
Likely dose
LCZ696 51 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03872778
NCT03872778Phase 2Completed
CompareCT.gov

A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerabiity, 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)

Advanced Accelerator Applications·interventional·Posted Mar 13, 2019·Updated Apr 30, 2026

In Brief

A Phase 2 clinical trial evaluating [177Lu]-NeoB, [68Ga]-NeoB, and 1 other intervention for Neoplasms. Completed, enrolled 35 participants across 11 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesAustria, France, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 13, 2019
Enrollment StartMay 24, 2019
Primary CompletionJan 7, 2025
Study CompletionNov 27, 2025
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.3 years ago

Interventions

[177Lu]-NeoBdrug

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

[68Ga]-NeoBdrug

\[68Ga\]-NeoB radioactive diagnostic agent

LCZ696drug

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