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18F-TRX · 1 trial · 10 indications
The proportion of participants with any treatment-emergent adverse events will be reported by grade and frequency per the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. All participants who receive the radiotracer injection will be evaluable.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Diagnostic (18F-TRX) | EXPERIMENTAL | Participants with any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging will receive multiple scans lasting 220 minutes after injection. Participants undergo blood sample collection and may undergo tumor biopsy during screening |
| Cohort 2: Diagnostic (18F-TRX) | EXPERIMENTAL | Participants with WHO grade 3 or 4 glioma, locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging, or metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the chest, abdomen and pelvis and whole body bone scan or prostate-specific membrane antigen (PSMA) PET scan (n = 30) will receive a single scan lasting 55-144 minutes after injection. Participants may undergo tumor biopsy during screening |
| Name | Type | Description |
|---|---|---|
| 18F-TRX | DRUG | Given Intravenously (IV) |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Imaging procedure |
| Tumor Biopsy | PROCEDURE | May undergo tumor biopsy |
| Blood Specimen Collection | PROCEDURE | Undergo blood sample collection |
Inclusion Criteria: * Age ≥ 18 years * Advanced solid tumor malignancy in one of the following cohorts: * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging * Cohort 2 (n = 50): * WHO grade 3 or 4 glioma - patients with known (by integr...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
18F-TRX is an investigational small molecule being studied for use in imaging solid tumors, including solid carcinoma, castration-resistant prostate carcinoma, locally advanced and metastatic clear cell renal cell carcinoma, metastatic malignant solid neoplasm, stage III and IV renal cell cancer, stage IVB prostate cancer, and malignant glioma. It is currently in Phase 1 clinical development.
18F-TRX is a small molecule imaging agent. Its specific molecular target has not been disclosed in available information. It is being evaluated in a Phase 1 trial for imaging various solid tumors, including renal cell carcinoma, prostate cancer, and glioma.
18F-TRX is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial to evaluate the imaging agent in patients with solid tumors.
18F-TRX is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants to evaluate its use in imaging solid tumors.
18F-TRX is being studied in one active Phase 1 clinical trial with the identifier NCT06942104, titled 'Imaging of Solid Tumors Using 18F-TRX'. The trial is recruiting 56 participants in the United States and is open to adults aged 18 years and older with various solid tumors.