NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

NCT06379217 · tracked via the Priya Life Science UK tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 1

Started

2024-07-29

Last updated

2026-07-24

Condition(s) studied

Metastatic Neuroendocrine Prostate Cancer

Investigational drug(s) / intervention(s)

[68Ga]Ga-PSMA-11[68Ga]GA-DOTA-TATE[68Ga]Ga-NeoB[177Lu]Lu-PSMA-617[177Lu]Lu-DOTA-TATE[177Lu]Lu-NeoBL-Lysine HCl-L-Arginine HCl, 2.5 %,Gonadotropin-releasing hormone (GnRH) analoguesGnRH antagonistsAntiemetics & antinauseantsMetoclopramide

[68Ga]Ga-PSMA-11: \[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)

[68Ga]GA-DOTA-TATE: \[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi)

[68Ga]Ga-NeoB: \[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi).

[177Lu]Lu-PSMA-617: \[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for 6 cycles.

[177Lu]Lu-DOTA-TATE: \[177Lu\]Lu-DOTA-TATE will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%) every 6 weeks for 6 cycles.

[177Lu]Lu-NeoB: \[177Lu\]Lu-NeoB will be administered as an intravenous infusion at a dose of 9.25 GBq (250mCi) every 6 weeks for 6 cycles

L-Lysine HCl-L-Arginine HCl, 2.5 %,: sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L)

Gonadotropin-releasing hormone (GnRH) analogues: Anatomical Therapeutic Chemical \[ATC\] code L02AE

GnRH antagonists: abarelix, degarelix, or relugolix

Antiemetics & antinauseants: ATC code A04A

Metoclopramide: ATC code A03FA01

Study summary

The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC).

Eligibility

Sex

MALE

Min age

18 Years

Max age

100 Years

Healthy volunteers

Key Inclusion criteria: * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following: * Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory. * Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory * Progression of visceral metastases in the absence of PSA progression * Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal limit with control for proton-pump inhibitors (PPI) drugs among concomitant treatment * Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss) * PSMA and/or SSTR2 and/or GRPR PET-positive participants, with at least one measurable lesion per RECIST 1.1 with moderate target expression in at least one of the 3 PET/CT scans per BICR assessment * Castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L) for participants with adenocarcinoma component or stable testosterone level for participants with pure neuroendocrine carcinoma * Recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapy * Participant has adequate bone marrow and organ function (as assessed by central laboratory for eligibility) * ECOG status =\< 2 Key Exclusion criteria: * Previous treatment with any of the following within 6 months prior to Screening: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation * Previous PSMA, SSTR2, or GRPR targeted radioligand therapy * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy or investigational therapy * History of CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity * Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * History or current diagnosis of ECG abnormalities indicating significant risk of safety for study participants Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI) — Baseline (baseline imaging is performed during the 42 day screening period)
Number/extent of lesions with at least a moderate update of any of the RLIs according to visual assessment scoring scale on each corresponding targeted PET/CT scan based on blinded independent central review (BICR) assessment.
Percentage changes in quantitative PET parameters. — Post-Baseline (from date of baseline imaging scans to post-baseline scans, at least 6 weeks after receiving the first cycle of radioligand treatment)
Percentage changes in quantitative PET/CT parameters (SUVmax, SUVmean, SUVpeak, target-positive Tumor Volume (target -TV), Total Lesion (target (TL-target)\] and changes in number of target-positive lesions (as per visual assessment) on each corresponding target PET/CT based on BICR.

Trial sites (9)

Facility	City	Region
Nebraska Cancer Specialists	Omaha	Nebraska
Memorial Sloan Kettering Cancer Ctr	New York	New York
Novartis Investigative Site	Nantes	France
Novartis Investigative Site	München	Germany
Novartis Investigative Site	Rostock	Germany
Novartis Investigative Site	L'Hospitalet de Llobregat	Barcelona
Novartis Investigative Site	Madrid	Spain
Novartis Investigative Site	Sutton	Surrey
Novartis Investigative Site	London	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06379217 on ClinicalTrials.gov ↗ ← All trials in the UK