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Virus Therapy
PSMA-Targeted Trillium Compounds + PTI-122 for Prostate Cancer
Phase < 1
Waitlist Available
Research Sponsored by Ratio Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 168 hours post-injection
Awards & highlights
No Placebo-Only Group
Summary
This trial tests special compounds that target prostate cancer cells in men with advanced disease. These compounds are labeled with a radioactive substance to track them in the body and are tested with and without a protective agent to see if it reduces side effects.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 168 hours post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 168 hours post-injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amount of radioactivity in blood
Amount of radiotracer absorbed by organs
Amount of radiotracer absorbed by tumor
Secondary study objectives
Amount of PTI-122 in blood
Incidence of adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Trillium Compound AloneExperimental Treatment1 Intervention
Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound
Group II: Trillium Compound + Single Dose PTI-122Experimental Treatment2 Interventions
Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
Group III: Trillium Compound + Multiple Dose PTI-122Experimental Treatment2 Interventions
Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PSMA-Targeted [In-111]-Labeled Trillium Compound
2022
Completed Early Phase 1
~30
PTI-122
2022
Completed Early Phase 1
~30
Find a Location
Who is running the clinical trial?
Ratio Therapeutics, Inc.Lead Sponsor
John Babich, PhDStudy DirectorRatio Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have undergone a minimum of 30 days' androgen deprivation hormone therapy or another form of hormonal treatment, or are to commence such therapies in the near future.If you have not had a prior PSMA PET scan, it may be provided as part of the study if you are eligible and have at least two PSMA positive lesions with one soft tissue lesion having an absolute minimum diameter of fifteen millimeters.You are not currently receiving treatment for any other type of cancer.You are not able or do not want to have SPECT/CT imaging done.You are not currently receiving PSMA-targeted therapy.You have an Eastern Cooperative Oncology Group performance score between 0 and 2.You are an adult male with metastatic prostate cancer.If a prior PSMA PET scan was conducted, it must have identified at least two PSMA-positive lesions with one soft tissue lesion having a minimum diameter of 15 millimeters.You are mentally and physically able to comprehend the study components, comply with them, and provide informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Trillium Compound Alone
- Group 2: Trillium Compound + Single Dose PTI-122
- Group 3: Trillium Compound + Multiple Dose PTI-122
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.