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ACTIVE NOT RECRUITING
NCT06379217
PHASE1

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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). Study is planning to enroll approximately 20 participants in \[177Lu\]Lu-PSMA-617 treatment arm, approximately 3 participants in \[177Lu\]Lu-NeoB treatment arm, and approximately 13 participants in \[177Lu\]Lu-DOTA-TATE treatment arm.

Official title: A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2024-07-29

Completion Date

2026-08-27

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

[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)

DRUG

[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)

DRUG

[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).

DRUG

[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.

DRUG

[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.

DRUG

[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

DRUG

L-Lysine HCl-L-Arginine HCl, 2.5 %,

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

DRUG

Gonadotropin-releasing hormone (GnRH) analogues

Anatomical Therapeutic Chemical \[ATC\] code L02AE

DRUG

GnRH antagonists

abarelix, degarelix, or relugolix

DRUG

Antiemetics & antinauseants

ATC code A04A

DRUG

Metoclopramide

ATC code A03FA01

Locations (11)

Stanford University

Palo Alto, California, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Novartis Investigative Site

London, United Kingdom