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

NCT05773703 | Completed Early Phase 1 FDA Drug

• 1 other identifier: RTX-PSMA-P101
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Amount of radiotracer absorbed by tumor

  Tumor uptake measured on imaging

  Over 168 hours post-injection

• Amount of radioactivity in blood

  Radioactivity measured pre- and post-radiotracer injection

  Over 168 hours post-injection

• Amount of radiotracer absorbed by organs

  Organ uptake measured on imaging

  Over 168 hours post-injection

Secondary Outcomes (2)

• Amount of PTI-122 in blood

  Over 168 hours post-injection

• Incidence of adverse events

  Over 168 hours post-injection

Study Arms (3)

Trillium Compound Alone

EXPERIMENTAL

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound

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

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

Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Drug: PTI-122

Interventions

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

Radiotracer

Trillium Compound + Multiple Dose PTI-122; Trillium Compound + Single Dose PTI-122; Trillium Compound Alone

PTI-122 DRUG

Cytoprotective agent

Trillium Compound + Multiple Dose PTI-122; Trillium Compound + Single Dose PTI-122

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ratio Therapeutics, Inc.: lead

Study Sites (4)

Biogenix Molecular

Miami, Florida, 33165, United States

Location

Advanced Molecular Imaging & Therapy

Glen Burnie, Maryland, 21061, United States

Location

XCancer Omaha/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Babich, PhD

  Ratio Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 17, 2023
• Study Start: December 8, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)