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CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03427476
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cancer Targeted Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: CTT1057 Phase 1

Detailed Description:

CTT has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other inhibitors in terms of affinity for PSMA, this unique class of phosphoramidate agents are the only known irreversible PSMA inhibitors. Due to its irreversible binding to PSMA and rapid uptake by PSMA-expressing cancer cells, accumulation at the cancer target is expected to be rapid, specific and sensitive. PSMA expression has been reported in renal cell carcinoma cells, making it possible that CTT1057 may have utility in detecting these tumors.

Ten patients will be enrolled in parallel in two cohorts:

  • (Cohort A) Patients with presumed metastases on conventional imaging, with at least one presumed metastatic lesion measuring > 1.5 cm in diameter (long-axis for non-node target lesions; short axis for lymph node), with planned biopsy of a metastatic lesion (N = 5).
  • (Cohort B) Patients with primary renal mass measuring > 7 cm on conventional imaging, with presumptive or histologically confirmed diagnosis of renal cell carcinoma, with planned nephrectomy. Patients may or may not have nodal or distant metastases on conventional imaging (N = 5) Participants receive a single IV dose (370 MBq, or 10 mCi) of CTT1057 in this trial. Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A (metastatic renal cell carcinoma) will undergo planned metastatic lesion biopsy within 12 weeks following CTT1057 PET imaging. Patients in cohort B (primary renal cell carcinoma) will have planned nephrectomy within 12 weeks following CTT1057 PET imaging.

The one-time nominal injected dose will be 370 MBq (10 mCi). Estimated mass dose is 20 µg of CTT1057. Dose will be in a volume of 3 - 5 mL, and will be injected intravenously as a bolus injection.

Vital signs, adverse event assessment, and 12 lead ECGs will be performed on day 1 before and after dosing.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metastatic RCC (> 3 lesions)
Patients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)
Drug: CTT1057

Cohort A: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A will undergo metastatic lesion biopsy (plus lymph node dissection) within 12 weeks after CTT1057 PET.

Cohort B: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort B (renal cell carcinoma) will have nephrectomy within 12 weeks of CTT1057 PET imaging.


Experimental: RCC patients with primary lesions > 7 mm in diameter
Cohort B: Patients with evidence of primary renal cell carcinoma and lesions > 7 cm (may also have metastatic disease) (N = 5)
Drug: CTT1057

Cohort A: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A will undergo metastatic lesion biopsy (plus lymph node dissection) within 12 weeks after CTT1057 PET.

Cohort B: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort B (renal cell carcinoma) will have nephrectomy within 12 weeks of CTT1057 PET imaging.





Primary Outcome Measures :
  1. Adverse event frequency as graded by Common Toxicity Criteria version 4.03 [ Time Frame: 7 days from time of injection ]

Secondary Outcome Measures :
  1. CTT1057 detection in blood samples [ Time Frame: Up to four hours from time of injection ]
  2. Compare the level of CTT1057 uptake on PET imaging of localized renal cell carcinoma with PSMA protein expression by immunohistochemistry from subsequent nephrectomy specimens [ Time Frame: 12 weeks ]
  3. Standardized Uptake Value (SUV) of CTT1057 PET for positive and negative tumor pathology results from primary renal cell carcinoma lesion tissue [ Time Frame: 4 hours ]
  4. Lesion-by-lesion basis tracer sensitivity ans specificity compared with standard imaging in metastatic renal cell carcinoma [ Time Frame: 4 hours ]
  5. Identification of positive lesions on CTT1057 PET in subjects with equivocal or negative conventional imaging scans [ Time Frame: 4 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427476


Contacts
Contact: Kenneth Gao (415) 353-9437 Kenneth.gao@ucsf.edu
Contact: Mina Lee (415) 353-4310 Mina.Lee@ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Kenneth Gao    415-353-9437    Kenneth.gao@ucsf.edu   
Principal Investigator: Spencer Behr, MD         
Principal Investigator: Rahul Aggarwal, MD         
Sponsors and Collaborators
Cancer Targeted Technology
University of California, San Francisco
Investigators
Study Chair: Beatrice Langton-Webster, PhD Cancer Targeted Technology

Responsible Party: Cancer Targeted Technology
ClinicalTrials.gov Identifier: NCT03427476     History of Changes
Other Study ID Numbers: 1057-102
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cancer Targeted Technology:
renal cell carcinoma
RCC
prostate specific membrane antigen
PSMA
metastatic renal cancer
positron emission tomography
PET

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neovascularization, Pathologic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Metaplasia
Pathologic Processes