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

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Drug: PTI-122

• Registration Number: NCT05773703
• Lead Sponsor: Ratio Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-08
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-17
• Status Verified: 2023-12
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Trillium Compound Alone	PSMA-Targeted [In-111]-Labeled Trillium Compound	Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound
Trillium Compound + Multiple Dose PTI-122	PTI-122	Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level
Trillium Compound + Single Dose PTI-122	PSMA-Targeted [In-111]-Labeled Trillium Compound	Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
Trillium Compound + Single Dose PTI-122	PTI-122	Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
Trillium Compound + Multiple Dose PTI-122	PSMA-Targeted [In-111]-Labeled Trillium Compound	Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level

Primary Outcome Measures

Name	Time	Method
Amount of radiotracer absorbed by organs	Over 168 hours post-injection	Organ uptake measured on imaging
Amount of radioactivity in blood	Over 168 hours post-injection	Radioactivity measured pre- and post-radiotracer injection
Amount of radiotracer absorbed by tumor	Over 168 hours post-injection	Tumor uptake measured on imaging

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Over 168 hours post-injection	Occurrence of adverse events during the study
Amount of PTI-122 in blood	Over 168 hours post-injection	PTI-122 measured pre- and post-dose

Trial Locations

Locations (4)

Advanced Molecular Imaging & Therapy; 🇺🇸 Glen Burnie, Maryland, United States

XCancer Omaha/Urology Cancer Center; 🇺🇸 Omaha, Nebraska, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Biogenix Molecular; 🇺🇸 Miami, Florida, United States