Thursday, November 13, 2025 11/13/2025

Alpha-Particle Emitter Peptide Receptor Targeted Radionuclide Therapy for Neuroendocrine Tumors

Award Number: R01CA243014
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Alpha-Particle Emitter Peptide Receptor Targeted Radionuclide Therapy for Neuroendocrine Tumors - PROJECT SUMMARY/ABSTRACT Peptide receptor radionuclide therapy (PRRT) with [177Lu]DOTATATE improves quality of life and survival in patients with advanced neuroendocrine tumors; however objective tumor regression is infrequent and complete responses are exceedingly rare. On the other hand, exciting-emerging evidence suggests that PRRT with alpha-emitters has the potential to extend PRRT to tumor regression and even complete response. In this study we propose to develop a new theranostic pair using [203Pb]PSC-TOC (imaging) / [212Pb]PSC-TOC (alpha emitter) for image-guided dosimetry based personalized therapy for neuroendocrine tumors. In Specific Aim 1 of the proposal, we will optimize the radiolabeling and production of [203/212Pb]PSC-TOC to prepare for its use in clinical trials and perform a preclinical dose escalation trial in immune-competent mice to investigate drug toxicity and the relation of toxicity with radiation dose (using residence time as a surrogate) to the organs. The accurate measurement of radiation dose from alpha-emitters is challenging due to dependence of the dose on the distribution of the radiopharmaceutical at cellular and subcellular level. In Specific Aim 2, we propose to develop a surrogate for organ dosimetry based on the residence time of the radiopharmaceutical in a human imaging trial with [203Pb]PSC-TOC, This methodology requires serial imaging over multiple days. We will then extend the dosimetry methodology to develop a predictive model to identify the best single imaging time point that predicts kidney accumulation, similar to our previous work with 90Y-DOTATOC, for translation of the dosimetry procedure into the clinical practice. Finally in Specific Aim 3 we will conduct a Phase 1 dose escalation trial of personalized dosimetry-guided therapy with [212Pb]PSC-TOC in patients with advanced stage NETs who have progressed or are refractory to conventional PRRT with beta emitters. The dose escalation paradigm will be based on escalating critical organ dose limits (using residence time as surrogate for dosimetry). The primary objective of the Phase 1 clinical trial will be the identification of the maximum safe kidney dose surrogate from treatment with [212Pb]PSC-TOC that should be used for a subsequent Phase 2 efficacy trial with the agent. As a secondary objective we will assess objective tumor response to PRRT with [212Pb]PSC-TOC. .


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $166,967 )
2024	2024	THE UNIVERSITY OF IOWA	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	6	7/2/2024	NON-COMPETING CONTINUATION	$166,967
														Subtotal = $166,967

Issue Date FY: 2023 ( Subtotal = $503,132 )
2023	2023	THE UNIVERSITY OF IOWA	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	5	5/30/2023	NON-COMPETING CONTINUATION	$503,132
														Subtotal = $503,132

Issue Date FY: 2022 ( Subtotal = $1 )
2022	2022	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	4	7/29/2022	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2021 ( Subtotal = $606,565 )
2021	2021	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	001	3	4/22/2021	NON-COMPETING CONTINUATION	$606,565
2021	2020	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	2	2/22/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $606,565

Issue Date FY: 2020 ( Subtotal = $612,761 )
2020	2020	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	2	4/29/2020	NON-COMPETING CONTINUATION	$612,761
														Subtotal = $612,761

Issue Date FY: 2019 ( Subtotal = $567,395 )
2019	2019	UNIVERSITY OF IOWA, THE	105 JESSUP HALL	IOWA CITY	IA	52242	JOHNSON	USA	Cancer Treatment Research	000	1	6/3/2019	NEW	$567,395
														Subtotal = $567,395

Grand Total All Awards = $2,456,821

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Alpha-Particle Emitter Peptide Receptor Targeted Radionuclide Therapy for Neuroendocrine Tumors

Award Number: R01CA243014

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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