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

• Sponsor: Ratio Therapeutics, Inc. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05773703
• Collaborator: (none)
• Enrollment: 36
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 8.8
• Patients Per Site: 12
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Drug: PTI-122	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Dec 8, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trillium Compound Alone Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound	Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound; Radiotracer
Experimental: Trillium Compound + Single Dose PTI-122 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; Radiotracer; Drug: PTI-122; Cytoprotective agent
Experimental: Trillium Compound + Multiple Dose PTI-122 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; Radiotracer; Drug: PTI-122; Cytoprotective agent

Outcome Measures

Primary Outcome Measures

1. Amount of radiotracer absorbed by tumor [Over 168 hours post-injection]

   Tumor uptake measured on imaging

2. Amount of radioactivity in blood [Over 168 hours post-injection]

   Radioactivity measured pre- and post-radiotracer injection

3. Amount of radiotracer absorbed by organs [Over 168 hours post-injection]

   Organ uptake measured on imaging

Secondary Outcome Measures

1. Amount of PTI-122 in blood [Over 168 hours post-injection]

   PTI-122 measured pre- and post-dose

2. Incidence of adverse events [Over 168 hours post-injection]

   Occurrence of adverse events during the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Molecular Imaging & Therapy	Glen Burnie	Maryland	United States	21061
2	GU Cancer Center	Omaha	Nebraska	United States	68130
3	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920

Sponsors and Collaborators

• Ratio Therapeutics, Inc.

Investigators

• Study Director: John Babich, PhD, Ratio Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ratio Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05773703
• Other Study ID Numbers: RTX-PSMA-P101
• First Posted: Mar 17, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 22, 2023