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NCT Number: NCT05773703

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Biogenix Molecular, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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

Drug

Radiotracer

PTI-122

Drug

Cytoprotective agent

Primary outcomes

  1. Amount of radiotracer absorbed by tumor

    Time frame: Over 168 hours post-injection

    Tumor uptake measured on imaging

  2. Amount of radioactivity in blood

    Time frame: Over 168 hours post-injection

    Radioactivity measured pre- and post-radiotracer injection

  3. Amount of radiotracer absorbed by organs

    Time frame: Over 168 hours post-injection

    Organ uptake measured on imaging

Secondary outcomes

  1. Amount of PTI-122 in blood

    Time frame: Over 168 hours post-injection

    PTI-122 measured pre- and post-dose

  2. Incidence of adverse events

    Time frame: Over 168 hours post-injection

    Occurrence of adverse events during the study

Sponsors and collaborators

Lead sponsor

Ratio Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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