Clinical trial · Interventional
CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma
CTT1057, a Small Molecular Inhibitor of Prostate Specific Membrane Antigen (PSMA), as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma (RCC): A Pilot Study
NCT03427476CI-TRIAL-00038261completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to test a novel diagnostic PET imaging agent for safety and biodistribution. The agent binds PSMA and is designed to detect Prostate Specific Membrane Antigen expressing tumors, such as has been described for some renal cell carcinoma tumors.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTT1057 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metastatic RCC (> 3 lesions)
- description
- Patients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)
- interventionNames
- Drug: CTT1057
- type
- EXPERIMENTAL
- label
- RCC patients with primary lesions > 7 mm in diameter
- description
- Cohort B: Patients with evidence of primary renal cell carcinoma and lesions \> 7 cm (may also have metastatic disease) (N = 5)
- interventionNames
- Drug: CTT1057
Primary outcomes (1)
- measure
- Adverse event frequency as graded by Common Toxicity Criteria version 4.03
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age ≥18 years old * Histologically confirmed renal cell carcinoma * Adequate organ function including: * \- Platelet count of \> 50,000/mm3 * \- Neutrophil count of \> 1000/mm3 * \- Serum Cr \< 1.5 x ULN or estimated GFR \> 60 ml/min based upon Cockroft-Gault equation * \- Proteinuria \< 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio * \- AST and ALT \< 2.5 x ULN (\< 5 x ULN in patients with known liver metastases) * \- Total bilirubin \< 1.5 x ULN (\< 3 x ULN in patients with known/suspected Gilbert's disease) * ECOG performance status of 0 or 1 * Able to provide written informed consent and willing to comply with protocol requirements * No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker * For participants of childbearing potential, not pregnant, and use of effective contraceptive methods during the trial and within 6 months following radiotracer injection * Cohort A only: Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan * Cohort B only: (N = 5 evaluable patients): Planned nephrectomy within 12 weeks following protocol scan Exclusion Criteria: * Patients with or with a history of uncontrolled bleeding diathesis * Inadequate venous access per assessment of treating health care provider * Receipt of radioisotope within 5 physical half-lives prior to trial enrollment * Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days * Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial. * Prior history of any other malignancy within past three years, except melanomatous skin cancer or carcinoma in situ.
References
Publications (0)
Data not yet available
No reference posted for this study.