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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05773703
Other study ID # RTX-PSMA-P101
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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