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

NCT ID: NCT05773703

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2023-12-12

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Each Trillium Compound will first be evaluated alone, then with single doses (5, 10, 15 mg) of the cytoprotective agent, PTI-122. Trillium Compound with two doses of PTI-122 at the preferred dose level may be studied if indicated.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Trillium Compound Alone

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound

Group Type EXPERIMENTAL

PSMA-Targeted [In-111]-Labeled Trillium Compound

Intervention Type DRUG

Radiotracer

Trillium Compound + Single Dose PTI-122

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg

Group Type EXPERIMENTAL

PSMA-Targeted [In-111]-Labeled Trillium Compound

Intervention Type DRUG

Radiotracer

PTI-122

Intervention Type DRUG

Cytoprotective agent

Trillium Compound + Multiple Dose PTI-122

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level

Group Type EXPERIMENTAL

PSMA-Targeted [In-111]-Labeled Trillium Compound

Intervention Type DRUG

Radiotracer

PTI-122

Intervention Type DRUG

Cytoprotective agent

Interventions

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PSMA-Targeted [In-111]-Labeled Trillium Compound

Radiotracer

Intervention Type DRUG

PTI-122

Cytoprotective agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ratio Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Babich, PhD

Role: STUDY_DIRECTOR

Ratio Therapeutics, Inc.

Locations

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Biogenix Molecular

Miami, Florida, United States

Site Status

Advanced Molecular Imaging & Therapy

Glen Burnie, Maryland, United States

Site Status

XCancer Omaha/Urology Cancer Center

Omaha, Nebraska, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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RTX-PSMA-P101

Identifier Type: -

Identifier Source: org_study_id