Clinical trial NCT05773703: Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: Ratio Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Amount of radiotracer absorbed by tumor
timeFrame: Over 168 hours post-injection
measure: Amount of radioactivity in blood
timeFrame: Over 168 hours post-injection
measure: Amount of radiotracer absorbed by organs
timeFrame: Over 168 hours post-injection
Secondary outcomes:
measure: Amount of PTI-122 in blood
timeFrame: Over 168 hours post-injection
measure: Incidence of adverse events
timeFrame: Over 168 hours post-injection
Other outcomes:
Locations:
city: Miami
country: United States
facility: Biogenix Molecular
state: Florida
city: Glen Burnie
country: United States
facility: Advanced Molecular Imaging & Therapy
state: Maryland
city: Omaha
country: United States
facility: XCancer Omaha/Urology Cancer Center
state: Nebraska
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: Ratio Therapeutics, Inc.
name: John Babich, PhD
role: STUDY_DIRECTOR
References: