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

NCT05773703 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

Radiotracer

DRUG

PTI-122

Cytoprotective agent

Sponsors & Collaborators

  • Ratio Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • John Babich, PhD · Ratio Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2023-12-12
Completion
2023-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773703 on ClinicalTrials.gov