Clinical trial · Interventional
Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA-Targeted [In-111]-Labeled Trillium Compound | Drug | — | UNRESOLVED |
| PTI-122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Trillium Compound Alone
- description
- Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound
- interventionNames
- Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound
- type
- EXPERIMENTAL
- label
- Trillium Compound + Single Dose PTI-122
- description
- Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
- interventionNames
- Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound
- Drug: PTI-122
- type
- EXPERIMENTAL
- label
- Trillium Compound + Multiple Dose PTI-122
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available