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

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CTT1057

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring renal cell carcinoma, RCC, prostate specific membrane antigen, PSMA, metastatic renal cancer, positron emission tomography, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Metastatic RCC (> 3 lesions)

RCC patients with primary lesions > 7 mm in diameter

Arm Description

Patients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)

Cohort B: Patients with evidence of primary renal cell carcinoma and lesions > 7 cm (may also have metastatic disease) (N = 5)

Outcomes

Primary Outcome Measures

Adverse event frequency as graded by Common Toxicity Criteria version 4.03

Secondary Outcome Measures

CTT1057 detection in blood samples

Compare the level of CTT1057 uptake on PET imaging of localized renal cell carcinoma with PSMA protein expression by immunohistochemistry from subsequent nephrectomy specimens

Standardized Uptake Value (SUV) of CTT1057 PET for positive and negative tumor pathology results from primary renal cell carcinoma lesion tissue

Lesion-by-lesion basis tracer sensitivity ans specificity compared with standard imaging in metastatic renal cell carcinoma

Identification of positive lesions on CTT1057 PET in subjects with equivocal or negative conventional imaging scans

Full Information

NCT ID

NCT03427476

First Posted

February 2, 2018

Last Updated

April 19, 2019

Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03427476

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

Keywords

renal cell carcinoma, RCC, prostate specific membrane antigen, PSMA, metastatic renal cancer, positron emission tomography, PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metastatic RCC (> 3 lesions)

Arm Type

Experimental

Arm Description

Patients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)

Arm Title

RCC patients with primary lesions > 7 mm in diameter

Arm Type

Experimental

Arm Description

Cohort B: Patients with evidence of primary renal cell carcinoma and lesions > 7 cm (may also have metastatic disease) (N = 5)

Intervention Type

Drug

Intervention Name(s)

CTT1057

Intervention Description

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 Measure Information:

Title

Adverse event frequency as graded by Common Toxicity Criteria version 4.03

Time Frame

7 days from time of injection

Secondary Outcome Measure Information:

Title

CTT1057 detection in blood samples

Time Frame

Up to four hours from time of injection

Title

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

Title

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

Title

Lesion-by-lesion basis tracer sensitivity ans specificity compared with standard imaging in metastatic renal cell carcinoma

Time Frame

4 hours

Title

Identification of positive lesions on CTT1057 PET in subjects with equivocal or negative conventional imaging scans

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatrice Langton-Webster, PhD

Organizational Affiliation

Cancer Targeted Technology

Official's Role

Study Chair

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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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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