Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773703
• Other study ID #: RTX-PSMA-P101
• Status: Completed
• Phase: Early Phase 1
• Start date: December 8, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: December 2023
• Source: Ratio Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.

Up to four PSMA-Targeted [In-111]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the [In-111]-labeled Trillium Compound may be co-administered with PTI-122.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult males with metastatic prostate cancer

• ECOG performance score 0-2

• Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated

• PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:

1. One soft tissue lesion measuring = 15 mm in the longest diameter with SUVmax lesion = SUVmean normal liver, OR

2. Two bone lesions measuring = 15 mm in the longest diameter with SUVmax lesion = 2 x SUVmax normal liver

• Able to understand and adhere to study requirements, and voluntarily give informed consent

Exclusion Criteria:

• No other malignancy undergoing treatment

• No PSMA-targeted therapy ongoing

• Inability or unwillingness to undergo SPECT/CT imaging

• Serum creatinine > 1.5 mg/dL or creatinine clearance =50 mL/min by Cockcroft-Gault estimation

• Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)

• Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PSMA-Targeted [In-111]-Labeled Trillium Compound
Radiotracer
• PTI-122
Cytoprotective agent

Locations

Country	Name	City	State
United States	Advanced Molecular Imaging & Therapy	Glen Burnie	Maryland
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Biogenix Molecular	Miami	Florida
United States	XCancer Omaha/Urology Cancer Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Ratio Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of radiotracer absorbed by tumor	Tumor uptake measured on imaging	Over 168 hours post-injection
Primary	Amount of radioactivity in blood	Radioactivity measured pre- and post-radiotracer injection	Over 168 hours post-injection
Primary	Amount of radiotracer absorbed by organs	Organ uptake measured on imaging	Over 168 hours post-injection
Secondary	Amount of PTI-122 in blood	PTI-122 measured pre- and post-dose	Over 168 hours post-injection
Secondary	Incidence of adverse events	Occurrence of adverse events during the study	Over 168 hours post-injection