Prostate CancerEarly Phase 1NCT05773703
Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer
A Early Phase 1 study testing PSMA-Targeted [In-111]-Labeled Trillium Compound and PTI-122 in people with Prostate Cancer, run by Ratio Therapeutics, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-Targeted [In-111]-Labeled Trillium Compound and PTI-122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2022to 12 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advanced Molecular Imaging & Therapy
Glen Burnie, Maryland, 21061
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Biogenix Molecular
Miami, Florida, 33165
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, 68130
About this study
Official title: A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy
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
- Prostate Cancer
- Being tested
- PSMA-Targeted [In-111]-Labeled Trillium Compound, PTI-122
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-Targeted [In-111]-Labeled Trillium CompoundDrug
Radiotracer
PTI-122Drug
Cytoprotective agent
| Study group | Role | What they receive |
|---|---|---|
| Trillium Compound Alone | Experimental | Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound Receives: Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound |
| Trillium Compound + Single Dose PTI-122 | Experimental | Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg Receives: Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Drug: PTI-122 |
| Trillium Compound + Multiple Dose PTI-122 | Experimental | Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level Receives: Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Drug: PTI-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of radiotracer absorbed by tumor
Tumor uptake measured on imaging
Measured: Over 168 hours post-injection
Amount of radioactivity in blood
Radioactivity measured pre- and post-radiotracer injection
Measured: Over 168 hours post-injection
Amount of radiotracer absorbed by organs
Organ uptake measured on imaging
Measured: Over 168 hours post-injection
Secondary outcomes (2)
Amount of PTI-122 in blood
PTI-122 measured pre- and post-dose
Measured: Over 168 hours post-injection
Incidence of adverse events
Occurrence of adverse events during the study
Measured: Over 168 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start8 Dec 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Babich, PhD, Study director, Ratio Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773703
- Sponsor's protocol ID
- RTX-PSMA-P101
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy
- ClinicalTrials.gov ID
- NCT05773703
- Acronym / sponsor ID
- RTX-PSMA-P101
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ratio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trillium Compound Alone | Experimental | Drug: PSMA-Targeted [In-111]-Labeled Trillium CompoundSingle dose of PSMA-Targeted [In-111]-Labeled Trillium Compound |
| Trillium Compound + Single Dose PTI-122 | Experimental | Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound, Drug: PTI-122Single 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 | Experimental | Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound, Drug: PTI-122Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Able to understand and adhere to study requirements, and voluntarily give informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-Targeted [In-111]-Labeled Trillium CompoundRadiotracer | Drug | Trillium Compound + Multiple Dose PTI-122, Trillium Compound + Single Dose PTI-122, Trillium Compound Alone |
| PTI-122Cytoprotective agent | Drug | Trillium Compound + Multiple Dose PTI-122, Trillium Compound + Single Dose PTI-122 |
Primary outcome
Amount of radiotracer absorbed by tumor
Time frame: Over 168 hours post-injection
Tumor uptake measured on imaging
Amount of radioactivity in blood
Time frame: Over 168 hours post-injection
Radioactivity measured pre- and post-radiotracer injection
Amount of radiotracer absorbed by organs
Time frame: Over 168 hours post-injection
Organ uptake measured on imaging
2 secondary outcomes
Amount of PTI-122 in blood
Time frame: Over 168 hours post-injection
Incidence of adverse events
Time frame: Over 168 hours post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Babich, PhD study director
Ratio Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PSMA-Targeted [In-111]-Labeled Trillium Compound and PTI-122 in people with Prostate Cancer, run by Ratio Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of radiotracer absorbed by tumor (time frame: Over 168 hours post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.