# Targeted alpha-emitter therapy of patients with PRRT refractory neuroendocrine tumors

> **NIH NIH R44** · RADIOMEDIX, INC. · 2021 · $548,182

## Abstract

PROJECT SUMMARY
A peptide receptor radionuclide therapy (PRRT) using beta-emitter-labeled somatostatin analogs has showed
increase in the progression-free-survival (PFS) of 177Lu-dotatate treated subjects, however the objective
response rate of this group is rather low only 18% compare to control group. In addition, the number of complete
responses and partial responses seen in the daily clinical practice in Lutathera treated patients is also low. This
is due to the heterogeneity of neuroendocrine tumors; advanced stage of disease at the time of diagnosis; and
more importantly tumor resistance to beta-emitter PRRT developed during the therapy. The targeted alpha-
emitter therapy (TAT) of neuroendocrine tumors can overcome these limitations and our Phase I dose escalation
studies of 212Pb-DOTAMTATE (AlphaMedix) provide clinical evidence supporting this statement. Our dose
Phase I study determined SAFE and HIGHLY EFFECTIVE DOSE of AlphaMedixTM in PRRT naïve patients with
metastatic neuroendocrine tumors regardless of the location of the primary tumor. All patients treated with this
effective dose have shown the Objective Radiologic Response (ORR 83%) by RECIST criteria and almost
complete response by NETSPOT PET/CT imaging. The main objective of proposed study is determination of
the safety, PK, and efficacy of Alphamedix in PRRT refractory patients who failed and progressed after Lutathera.
This will be accomplished during Phase I clinical study (amended IND 135150), followed by Phase II study
(Protocol Number: RMX-Alpha-R020).
OBJECTIVE 1. Phase I safety, efficacy and PK studies of the effective dose of Alphamedix in PRRT-refractory
patients regardless the primary origin the tumor. With successful completion of this objective, we will confirm
the efficacy and safety of recommended doses of Alphamedix, compile all modules for Phase II clinical studies
and request type B meeting and submit Phase II clinical protocol to IRB and FDA.
OBJECTIVE 2. Phase II non-randomized, open-label, multi-center clinical studies of AlphaMedix in PRRT
refractory patients. With successful completion of the objective, we will determine the median Progression free
survival (mPFS) and the Overall Survival (OS) of NETs patients, as well as their Time to Tumor Progression
(TTP), and safety of the recommended doses of AlphaMedix.

## Key facts

- **NIH application ID:** 10324229
- **Project number:** 1R44CA265421-01
- **Recipient organization:** RADIOMEDIX, INC.
- **Principal Investigator:** Izabela Tworowska
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $548,182
- **Award type:** 1
- **Project period:** 2021-09-07 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10324229

## Citation

> US National Institutes of Health, RePORTER application 10324229, Targeted alpha-emitter therapy of patients with PRRT refractory neuroendocrine tumors (1R44CA265421-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10324229. Licensed CC0.

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