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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ratio Therapeutics, Inc.

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

• If prior PSMA PET scan done, revealed at least 2 PSMA positive lesions with one soft tissue lesion having a minimum diameter of 15 mm

• If no prior PSMA PET scan, it may be provided as part of the study if patient is otherwise eligible; must have at least 2 PSMA positive lesions with one soft tissue lesion having a minimum diameter of 15 mm

• 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