Prostate Cancer
Conditions
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.
Interventions
DRUGPSMA-Targeted [In-111]-Labeled Trillium Compound
Radiotracer
DRUGPTI-122
Cytoprotective agent
Sponsors
Ratio Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of radiotracer absorbed by tumor | Over 168 hours post-injection | Tumor 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 organs | Over 168 hours post-injection | Organ uptake measured on imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of PTI-122 in blood | Over 168 hours post-injection | PTI-122 measured pre- and post-dose |
| Incidence of adverse events | Over 168 hours post-injection | Occurrence of adverse events during the study |
Countries
United States
Outcome results
None listed